<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/NCT03816306</url>
  </required_header>
  <id_info>
    <org_study_id>31640</org_study_id>
    <nct_id>NCT03816306</nct_id>
  </id_info>
  <brief_title>Six Months Clinical and Echocardiographic Outcome of ARNI LCZ696 Therapy in HFrEF Patients</brief_title>
  <official_title>Six Months Clinical and Echocardiographic Outcome of Angiotensin Receptor-Neprilysin Inhibitor (ARNI) LCZ696 Therapy in Heart Failure Patients With Reduced Ejection Fraction (HFrEF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohammed Alnims</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the clinical and echocardiographic outcome of LCZ696 therapy in HFrEF (NYHA Class&#xD;
      II - IV and EF =≤ 40%).patients, in addition to the efficacy of LCZ696 in reducing mortality&#xD;
      and rehospitalisation rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants That Had Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization.</measure>
    <time_frame>6 Months after starting LCZ696 Therapy</time_frame>
    <description>Number of participants that had either CV death or HF hospitalization due to HF.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 for The Minnesota Living with Heart Failure Questionnaire (MLHFQ).</measure>
    <time_frame>6 Months after starting LCZ696 Therapy</time_frame>
    <description>Change From Baseline to Month 6 for the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The questionnaire was designed as a self-administered measure of the effects of heart failure and treatments for heart failure on patients' quality of life. The questionnaire has 21 items assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. The response scale for all 21 items on the MLHF is based on a 6-point ( from 0 to 5 ). Scores are transformed to a range of 0-105, in which higher scores reflect better health status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients - All-cause Mortality.</measure>
    <time_frame>6 Months after starting LCZ696 Therapy</time_frame>
    <description>Number of patients - All-cause mortality. All-cause mortality is common in HF patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With First Confirmed Renal Dysfunction.</measure>
    <time_frame>6 Months after starting LCZ696 Therapy</time_frame>
    <description>Number of patients with first confirmed renal dysfunction ( a decrease in the eGFR of at least 50% or a decrease of more than 30 ml per minute per 1.73 m2 to less than 60 ml per minute per 1.73 m2 ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients with Changes in The Left Ventricular Systolic Function (EF).</measure>
    <time_frame>6 Months after starting LCZ696 Therapy</time_frame>
    <description>Number of Patients with improvement in the ejection fraction.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Heart Failure With Reduced Ejection Fraction</condition>
  <arm_group>
    <arm_group_label>Single group study</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LCZ 696</intervention_name>
    <description>LCZ696 is an Angiotensin receptor neprilysin inhibitor. It's composed of Sacubitril/Valsartan. LCZ696 starting dose 50 mg P.O. BID, LCZ696 100 mg P.O. BID and up-titration to LCZ696 200 mg P.O. BID.</description>
    <arm_group_label>Single group study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any Patients with HFrEF (EF ≤ 40%) above 18 year old.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥18 year old.&#xD;
&#xD;
          2. Functional class using New York Heart Association (NYHA) classification class II, III&#xD;
             or IV %).&#xD;
&#xD;
          3. Left ventricular systolic dysfunction using transthoracic echocardiography with EF ≤&#xD;
             40%.&#xD;
&#xD;
          4. Who was already taking ACE inhibitors or ARBs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Symptomatic hypotension.&#xD;
&#xD;
          2. Systolic blood pressure &lt;100 mm Hg.&#xD;
&#xD;
          3. Estimated glomerular filtration rate (eGFR) &lt;30 mL/min/1.73 m2.&#xD;
&#xD;
          4. History of angioedema.&#xD;
&#xD;
          5. Hisotry of unacceptable side effects while on while on treatment with an ACE-inhibitor&#xD;
             or ARBs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magdy Abdelhamid, MD, FACC, FESC, FSCAI</last_name>
    <role>Study Director</role>
    <affiliation>Professor of Cardiovascular Medicine, Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohammed Alnims</investigator_full_name>
    <investigator_title>Doctor, Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sacubitril and valsartan sodium hydrate drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03816306
org study id: 31640
nct id: NCT03816306
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To evaluate the clinical and echocardiographic outcome of LCZ696 therapy in HFrEF (NYHA Class
      II - IV and EF =≤ 40%).patients, in addition to the efficacy of LCZ696 in reducing mortality
      and rehospitalisation rate.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants That Had Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization.
time frame: 6 Months after starting LCZ696 Therapy
description: Number of participants that had either CV death or HF hospitalization due to HF.
measure: Change From Baseline to Month 6 for The Minnesota Living with Heart Failure Questionnaire (MLHFQ).
time frame: 6 Months after starting LCZ696 Therapy
description: Change From Baseline to Month 6 for the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The questionnaire was designed as a self-administered measure of the effects of heart failure and treatments for heart failure on patients' quality of life. The questionnaire has 21 items assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. The response scale for all 21 items on the MLHF is based on a 6-point ( from 0 to 5 ). Scores are transformed to a range of 0-105, in which higher scores reflect better health status.
measure: Number of Patients - All-cause Mortality.
time frame: 6 Months after starting LCZ696 Therapy
description: Number of patients - All-cause mortality. All-cause mortality is common in HF patients.
measure: Number of Patients With First Confirmed Renal Dysfunction.
time frame: 6 Months after starting LCZ696 Therapy
description: Number of patients with first confirmed renal dysfunction ( a decrease in the eGFR of at least 50% or a decrease of more than 30 ml per minute per 1.73 m2 to less than 60 ml per minute per 1.73 m2 ).
measure: Number of Patients with Changes in The Left Ventricular Systolic Function (EF).
time frame: 6 Months after starting LCZ696 Therapy
description: Number of Patients with improvement in the ejection fraction.
arm group label: Single group study
intervention type: Drug
intervention name: LCZ 696
description: LCZ696 is an Angiotensin receptor neprilysin inhibitor. It's composed of Sacubitril/Valsartan. LCZ696 starting dose 50 mg P.O. BID, LCZ696 100 mg P.O. BID and up-titration to LCZ696 200 mg P.O. BID.
arm group label: Single group study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Magdy Abdelhamid, MD, FACC, FESC, FSCAI
role: Study Director
affiliation: Professor of Cardiovascular Medicine, Cairo University
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Mohammed Alnims
investigator title: Doctor, Investigator
mesh term: Heart Failure
mesh term: Sacubitril and valsartan sodium hydrate drug combination
sharing ipd: No