xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06004453</url>
    </required_header>
    <id_info>
      <org_study_id>CLCZ696BDE06</org_study_id>
      <nct_id>NCT06004453</nct_id>
    </id_info>
    <brief_title>Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care</brief_title>
    <acronym>CONNECT</acronym>
    <official_title>Characterizing Guideline Adoption and Treatment Quality in Clinical Routine of German HFrEF Care in Heart Failure Units and Independent Centers Utilizing Established Quality Indicators</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novartis</source>
    <brief_summary>
      <textblock>
        This is a multicenter, non-randomized, non-interventional cohort study with prospective and&#xD;
        retrospective collection of primary data on heart failure with reduced ejection fraction&#xD;
        (HFrEF) patient treatment and care following a decompensation event in different types of&#xD;
        Heart Failure Unit (HFU) or non-HFU centers across Germany.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aims to describe quality of care of HFrEF patients following a decompensation&#xD;
        event in different center types (=settings) utilizing the quality indicators for the care and&#xD;
        outcomes of adults with heart failure as specified by the Heart Failure Association in 2022.&#xD;
  &#xD;
        No strict visit schedule will be imposed on participants to avoid interference with routine&#xD;
        clinical care. HFrEF patients will be treated according to the local routine in terms of&#xD;
        medication, visit frequency and types of assessments performed and only these data will be&#xD;
        collected as part of the study from patient files.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 5, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint</measure>
      <time_frame>6 months</time_frame>
      <description>Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based QI composite endpoint defined by the number of times each of secondary endpoints has been accomplished divided by chances to accomplish them as average per center type.&#xD;
  To describe the quality of Heart Failure (HF) patient care in Heart Failure Unit (HFU) and non-HFU centers utilizing QIs as suggested by the 2021 European Society of Cardiology HF guideline.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of sites with a dedicated multidisciplinary team to manage patients with HF</measure>
      <time_frame>Baseline</time_frame>
      <description>To describe the structural framework of the participating centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of sites with dedicated trained healthcare professionals to deliver HF specific education to facilitate patient self-care.</measure>
      <time_frame>Baseline</time_frame>
      <description>To describe the structural framework of the participating centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(A) Proportion of patients with HF who have a documentation of their HF clinical type</measure>
      <time_frame>Baseline</time_frame>
      <description>HF clinical type: Heart failure with reduced ejection fraction (HFrEF), HF with a midrange ejection fraction (HFmrEF), HF with preserved ejection fraction (HFpEF).&#xD;
  To describe the patient assessment in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(B) Proportion of patients with a documentation of their electrocardiogram findings</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the patient assessment in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(C) Proportion of patients who have their natriuretic peptides (NPs) measured (within a 3-month period from the time of decompensation)</measure>
      <time_frame>3 months</time_frame>
      <description>To describe the patient assessment in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(D) Proportion of patients who have their blood tests documented</measure>
      <time_frame>3 months</time_frame>
      <description>To describe the patient assessment in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(E) Proportion of patients hospitalized with HF who have been referred for a cardiac rehabilitation program</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the patient assessment in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(F) Proportion of patients hospitalized with HF who have a follow-up review by a healthcare professional within 4 weeks of hospital discharge</measure>
      <time_frame>4 weeks</time_frame>
      <description>To describe the patient assessment in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(G) Proportion of patients treated with beta-blocker bisoprolol, carvedilol, sustained-release metoprolol succinate, or nebivolol in the absence of any contraindications as defined by Aktaa et al 2022</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(H) Proportion of patients treated with an Angiotensin-converting enzymes (ACE) inhibitor, Angiotensin receptor blocker (ARB) or Angiotensin receptor-neprilysin inhibitor (ARNI) in the absence of any contraindications</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(I) Proportion of patients treated with an Mineralocorticoid receptor antagonist (MRA) in the absence of any contraindications</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(J) Proportion of patients treated with a Sodium-glucose co-transporter 2 (SGLT2) inhibitor in the absence of any contraindications</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients receiving ARNI instead of ACEi/ARB as first-line treatment</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with HF who are prescribed loop diuretic therapy if they have evidence of fluid retention</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to treatment of the above 4 individual treatment classes and time to treatment with all four classes together</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of days covered with all four treatment classes</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(K) Proportion of symptomatic patients with HFrEF in sinus rhythm with a QRS duration ≥150ms and left bundle branch block QRS morphology and with LVEF ≤35% despite ≥3 months optimal medical therapy who are offered cardiac resynchronization therapy</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the therapy optimization in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>(L) Proportion of symptomatic patients with HF, LVEF ≤35% despite ≥3 months of optimal medical therapy, and ischemic heart disease (IHD) who are offered primary prevention implantable cardioverter defibrillator</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the therapy optimization in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who have an assessment of their Health-related quality of life (HRQoL) using a validated tool</measure>
      <time_frame>6 months</time_frame>
      <description>To describe the utilization of HRQoL assessments in different types of HFU and non-HFU centers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients who are eligible for and have accomplished secondary endpoint g-j divided by the number of patients who are eligible for g-j</measure>
      <time_frame>6 months</time_frame>
      <description>To describe quality of treatment utilizing an all-or-none composite QI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of HF hospitalizations, stratified by bed type</measure>
      <time_frame>6 months</time_frame>
      <description>Where a patient has multiple HF hospitalization stays, each hospitalization will be counted.&#xD;
  To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>6 months</time_frame>
      <description>Length of hospital stay will be considered as the time from admission date until discharge for each HF hospitalization.&#xD;
  To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of HF hospitalizations per patient</measure>
      <time_frame>6 months</time_frame>
      <description>To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of newly implanted devices</measure>
      <time_frame>6 months</time_frame>
      <description>implanted devices: implantable cardioverter defibrillator (ICD), Cardiac resynchronization therapy (CRT), combination of ICD and CRT (CRT-D).&#xD;
  To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of valve interventions</measure>
      <time_frame>6 months</time_frame>
      <description>To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with medical history of selected comorbidities</measure>
      <time_frame>Baseline</time_frame>
      <description>To describe the HFrEF patient population with a recent decompensation</description>
    </secondary_outcome>
    <number_of_groups>5</number_of_groups>
    <enrollment type="Anticipated">1250</enrollment>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>Cohort A</arm_group_label>
      <description>Supra-regional HFU Centers and HFU Focus Hospitals</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort B</arm_group_label>
      <description>Non-HFU Hospitals</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort C</arm_group_label>
      <description>HFU Residential Cardiologists</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort D</arm_group_label>
      <description>Non-HFU Residential Cardiologists</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort E</arm_group_label>
      <description>General practitioners</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Heart Failure medications</intervention_name>
      <description>There is no treatment allocation. Patients are allocated to the respective cohort based on the treating physician enrolling them in the study. Patients are treated according to the local prescribing information and routine medical practice.</description>
      <arm_group_label>Cohort A</arm_group_label>
      <arm_group_label>Cohort B</arm_group_label>
      <arm_group_label>Cohort C</arm_group_label>
      <arm_group_label>Cohort D</arm_group_label>
      <arm_group_label>Cohort E</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Heart failure with reduced ejection fraction patients with a recent decompensation event&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients who provide written informed consent to participate in the study&#xD;
  &#xD;
            2. Male or female patients ≥ 18 years of age&#xD;
  &#xD;
            3. Patients with diagnosis of heart failure with reduced ejection fraction (HFrEF) and HF&#xD;
               treatment according to the summaries of product characteristics (SmPCs)&#xD;
  &#xD;
            4. Decompensation event up to three months prior to inclusion&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Simultaneous or planned participation in an interventional research study&#xD;
  &#xD;
            2. Participation in this study at another site e.g. in a HFU network&#xD;
  &#xD;
            3. Patients incapable of understanding and signing the informed consent form&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Novartis Pharmaceuticals</last_name>
      <role>Study Director</role>
      <affiliation>Novartis Pharmaceuticals</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Novartis Pharmaceuticals</last_name>
      <phone>+41613241111</phone>
      <email>novartis.email@novartis.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Novartis Pharmaceuticals</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Winsen</city>
          <state>Lower Saxony</state>
          <zip>21423</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Braunschschweig</city>
          <state>Niedersachsen</state>
          <zip>38126</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Frankenthal</city>
          <state>Pfalz</state>
          <zip>67227</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Kaiserslautern</city>
          <state>Rhineland-Palatinate</state>
          <zip>67655</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Chemnitz</city>
          <state>Saxony</state>
          <zip>09113</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Pirna</city>
          <state>Saxony</state>
          <zip>01796</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Bad Neustadt</city>
          <zip>97616</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Bechhofen</city>
          <zip>66894</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Berlin</city>
          <zip>13053</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Berlin</city>
          <zip>D 10559</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Bexbach</city>
          <zip>66450</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Biedenkopf</city>
          <zip>35216</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Breuberg</city>
          <zip>64747</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Brilon</city>
          <zip>59929</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Brueel</city>
          <zip>19412</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Chemnitz</city>
          <zip>09116</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Coburg</city>
          <zip>96450</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Dessau-Rosslau</city>
          <zip>06847</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Dinkelsbuhl</city>
          <zip>91550</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Dresden</city>
          <zip>01277</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Dresden</city>
          <zip>01397</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Duesseldorf</city>
          <zip>40225</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Ehingen</city>
          <zip>89584</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Ehringshausen</city>
          <zip>35630</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Farchant</city>
          <zip>82490</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Frankfurt</city>
          <zip>60316</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Freiberg</city>
          <zip>09559</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Giengen</city>
          <zip>89537</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Goeppingen</city>
          <zip>73033</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Halle S</city>
          <zip>06120</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Hamburg</city>
          <zip>20095</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Heidelberg</city>
          <zip>69115</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Heidelberg</city>
          <zip>69120</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Hoppegarten</city>
          <zip>15366</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Hoyerswerda</city>
          <zip>02977</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Ingelheim</city>
          <zip>55218</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Jerichow</city>
          <zip>39319</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Kassel</city>
          <zip>34121</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Kiel</city>
          <zip>24106</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Kitzingen</city>
          <zip>97318</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Lahnau</city>
          <zip>35633</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Limbach-Oberfrohna</city>
          <zip>09212</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Ludwigshafen</city>
          <zip>67067</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Lutherstadt Wittenberg</city>
          <zip>06886</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Markkleeberg</city>
          <zip>04416</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Moers</city>
          <zip>47441</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Muellheim</city>
          <zip>79379</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Nuernberg</city>
          <zip>90461</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Oberhausen</city>
          <zip>46149</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Osnabrueck</city>
          <zip>49074</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Papenburg</city>
          <zip>26871</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Peine</city>
          <zip>31224</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Potsdam</city>
          <zip>14471</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Radebeul</city>
          <zip>01445</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Rastatt</city>
          <zip>76437</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Remscheid</city>
          <zip>42859</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Rostock</city>
          <zip>18107</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Rotenburg an der Fulda</city>
          <zip>36199</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Saarlouis</city>
          <zip>66740</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Schoenebeck</city>
          <zip>39218</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Schwandorf</city>
          <zip>92421</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Siegen</city>
          <zip>57072</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Speyer</city>
          <zip>67346</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Stadtbergen</city>
          <zip>86391</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Stahnsdorf</city>
          <zip>14532</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Ulm</city>
          <zip>89077</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Wedemark</city>
          <zip>30900</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Wenden</city>
          <zip>57482</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Winsen</city>
          <zip>21423</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Wismar</city>
          <zip>23966</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Heart Failure</keyword>
    <keyword>HFrEF</keyword>
    <keyword>patient management</keyword>
    <keyword>quality of care</keyword>
    <keyword>quality indicators</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06004453
  org study id: CLCZ696BDE06
  nct id: NCT06004453
  lead sponsor: 
  This is a multicenter, non-randomized, non-interventional cohort study with prospective and
        retrospective collection of primary data on heart failure with reduced ejection fraction
        (HFrEF) patient treatment and care following a decompensation event in different types of
        Heart Failure Unit (HFU) or non-HFU centers across Germany.
  This study aims to describe quality of care of HFrEF patients following a decompensation
        event in different center types (=settings) utilizing the quality indicators for the care and
        outcomes of adults with heart failure as specified by the Heart Failure Association in 2022.
  
        No strict visit schedule will be imposed on participants to avoid interference with routine
        clinical care. HFrEF patients will be treated according to the local routine in terms of
        medication, visit frequency and types of assessments performed and only these data will be
        collected as part of the study from patient files.
  observational model: Cohort
  time perspective: Other
  measure: Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based quality indicator (QI) composite endpoint
  time frame: 6 months
  description: Quality of care and guideline adoption score in different structural settings as assessed by an opportunity-based QI composite endpoint defined by the number of times each of secondary endpoints has been accomplished divided by chances to accomplish them as average per center type.
  To describe the quality of Heart Failure (HF) patient care in Heart Failure Unit (HFU) and non-HFU centers utilizing QIs as suggested by the 2021 European Society of Cardiology HF guideline.
  measure: Proportion of sites with a dedicated multidisciplinary team to manage patients with HF
  time frame: Baseline
  description: To describe the structural framework of the participating centers.
  measure: Percentage of sites with dedicated trained healthcare professionals to deliver HF specific education to facilitate patient self-care.
  time frame: Baseline
  description: To describe the structural framework of the participating centers.
  measure: (A) Proportion of patients with HF who have a documentation of their HF clinical type
  time frame: Baseline
  description: HF clinical type: Heart failure with reduced ejection fraction (HFrEF), HF with a midrange ejection fraction (HFmrEF), HF with preserved ejection fraction (HFpEF).
  To describe the patient assessment in different types of HFU and non-HFU centers.
  measure: (B) Proportion of patients with a documentation of their electrocardiogram findings
  time frame: 6 months
  description: To describe the patient assessment in different types of HFU and non-HFU centers.
  measure: (C) Proportion of patients who have their natriuretic peptides (NPs) measured (within a 3-month period from the time of decompensation)
  time frame: 3 months
  description: To describe the patient assessment in different types of HFU and non-HFU centers.
  measure: (D) Proportion of patients who have their blood tests documented
  time frame: 3 months
  description: To describe the patient assessment in different types of HFU and non-HFU centers.
  measure: (E) Proportion of patients hospitalized with HF who have been referred for a cardiac rehabilitation program
  time frame: 6 months
  description: To describe the patient assessment in different types of HFU and non-HFU centers.
  measure: (F) Proportion of patients hospitalized with HF who have a follow-up review by a healthcare professional within 4 weeks of hospital discharge
  time frame: 4 weeks
  description: To describe the patient assessment in different types of HFU and non-HFU centers.
  measure: (G) Proportion of patients treated with beta-blocker bisoprolol, carvedilol, sustained-release metoprolol succinate, or nebivolol in the absence of any contraindications as defined by Aktaa et al 2022
  time frame: 6 months
  description: To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
  measure: (H) Proportion of patients treated with an Angiotensin-converting enzymes (ACE) inhibitor, Angiotensin receptor blocker (ARB) or Angiotensin receptor-neprilysin inhibitor (ARNI) in the absence of any contraindications
  time frame: 6 months
  description: To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
  measure: (I) Proportion of patients treated with an Mineralocorticoid receptor antagonist (MRA) in the absence of any contraindications
  time frame: 6 months
  description: To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
  measure: (J) Proportion of patients treated with a Sodium-glucose co-transporter 2 (SGLT2) inhibitor in the absence of any contraindications
  time frame: 6 months
  description: To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
  measure: Proportion of patients receiving ARNI instead of ACEi/ARB as first-line treatment
  time frame: 6 months
  description: To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
  measure: Proportion of patients with HF who are prescribed loop diuretic therapy if they have evidence of fluid retention
  time frame: 6 months
  description: To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
  measure: Time to treatment of the above 4 individual treatment classes and time to treatment with all four classes together
  time frame: 6 months
  description: To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
  measure: Percentage of days covered with all four treatment classes
  time frame: 6 months
  description: To describe the initial treatment algorithm of HFrEF patients following a decompensation in different types of HFU and non-HFU centers.
  measure: (K) Proportion of symptomatic patients with HFrEF in sinus rhythm with a QRS duration ≥150ms and left bundle branch block QRS morphology and with LVEF ≤35% despite ≥3 months optimal medical therapy who are offered cardiac resynchronization therapy
  time frame: 6 months
  description: To describe the therapy optimization in different types of HFU and non-HFU centers.
  measure: (L) Proportion of symptomatic patients with HF, LVEF ≤35% despite ≥3 months of optimal medical therapy, and ischemic heart disease (IHD) who are offered primary prevention implantable cardioverter defibrillator
  time frame: 6 months
  description: To describe the therapy optimization in different types of HFU and non-HFU centers.
  measure: Proportion of patients who have an assessment of their Health-related quality of life (HRQoL) using a validated tool
  time frame: 6 months
  description: To describe the utilization of HRQoL assessments in different types of HFU and non-HFU centers.
  measure: Number of patients who are eligible for and have accomplished secondary endpoint g-j divided by the number of patients who are eligible for g-j
  time frame: 6 months
  description: To describe quality of treatment utilizing an all-or-none composite QI.
  measure: Number of HF hospitalizations, stratified by bed type
  time frame: 6 months
  description: Where a patient has multiple HF hospitalization stays, each hospitalization will be counted.
  To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
  measure: Length of hospital stay
  time frame: 6 months
  description: Length of hospital stay will be considered as the time from admission date until discharge for each HF hospitalization.
  To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
  measure: Number of HF hospitalizations per patient
  time frame: 6 months
  description: To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
  measure: Number of newly implanted devices
  time frame: 6 months
  description: implanted devices: implantable cardioverter defibrillator (ICD), Cardiac resynchronization therapy (CRT), combination of ICD and CRT (CRT-D).
  To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
  measure: Number of valve interventions
  time frame: 6 months
  description: To describe healthcare resource utilization in patients hospitalized with HF during 6 months follow-up.
  measure: Number of participants with medical history of selected comorbidities
  time frame: Baseline
  description: To describe the HFrEF patient population with a recent decompensation
  arm group label: Cohort A
  description: Supra-regional HFU Centers and HFU Focus Hospitals
  arm group label: Cohort B
  description: Non-HFU Hospitals
  arm group label: Cohort C
  description: HFU Residential Cardiologists
  arm group label: Cohort D
  description: Non-HFU Residential Cardiologists
  arm group label: Cohort E
  description: General practitioners
  intervention type: Other
  intervention name: Heart Failure medications
  description: There is no treatment allocation. Patients are allocated to the respective cohort based on the treating physician enrolling them in the study. Patients are treated according to the local prescribing information and routine medical practice.
  arm group label: Cohort A
  arm group label: Cohort B
  arm group label: Cohort C
  arm group label: Cohort D
  arm group label: Cohort E
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  last name: Novartis Pharmaceuticals
  phone: +41613241111
  email: novartis.email@novartis.com
  last name: Novartis Pharmaceuticals
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
  facility: 
  status: Recruiting
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  status: Recruiting
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  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
  facility: 
  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: Germany
  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: No