<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/NCT03026114</url>
  </required_header>
  <id_info>
    <org_study_id>MuglaSKU</org_study_id>
    <nct_id>NCT03026114</nct_id>
  </id_info>
  <brief_title>A ComPrehensive, ObservationaL Registry of Heart FaiLure With Mid-range and Preserved EjectiON Fraction</brief_title>
  <acronym>APOLLON</acronym>
  <official_title>A ComPrehensive, ObservationaL Registry of Heart FaiLure With Mid-range and Preserved EjectiON Fraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Muğla Sıtkı Koçman University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Muğla Sıtkı Koçman University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%),&#xD;
      termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or&#xD;
      preserved ejection fraction (HFpEF, EF ≥ 50%).&#xD;
&#xD;
      Up to now, there are no large scale studies evaluating patients with HFmrEF and/or HFpEF in&#xD;
      Turkey. Scarce data are available in the middle-east populations in general and Turkish&#xD;
      patients in particular, who have different etiology, ethnic, cultural backgrounds and risk&#xD;
      factors from those patients in the West. The aim of this study was to study Turkish patients&#xD;
      with HFmrEF and HFpEF, and define their clinical characteristics and the signs and symptoms&#xD;
      of heart failure, echocardiographic findings and medications at admission. With this national&#xD;
      study, we will evaluate how recommendations of most recent European guidelines regarding&#xD;
      pharmacological and non-pharmacological treatments are adopted in clinical practice. We will&#xD;
      also evaluate the prevalence of the clinical profiles of patients with HFmrEF and HFpEF,&#xD;
      according to the definitions proposed by the European Society of Cardiology, and to&#xD;
      investigate their appropriateness in characterizing patients with different clinical&#xD;
      presentations and needs.&#xD;
&#xD;
      Assessed outcomes included the causes of decompensation, use of medications, care quality&#xD;
      indicators.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      To describe the demographic, clinical, and echocardiographic characteristics and management&#xD;
      of outpatients heart failure (HF) with midrange ejection fraction (HFmrEF) and heart failure&#xD;
      with preserved ejection fraction (HFpEF) followed by a representative setting of cardiology&#xD;
      centres.&#xD;
&#xD;
      Background:&#xD;
&#xD;
      About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%),&#xD;
      termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or&#xD;
      preserved ejection fraction (HFpEF, EF ≥ 50%). Presentation and pathophysiology of HFmrEF and&#xD;
      HFpEF is heterogeneous and its management remains a challenge since evidence of therapeutic&#xD;
      benefits on outcome is scarce. Up to now, there are no large scale studies evaluating&#xD;
      patients with HFmrEF and/or HFpEF in Turkey.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      Several studies have been conducted in western countries differentiating features of&#xD;
      epidemiology, treatment, and outcomes among patients with preserved and reduced EF. Scarce&#xD;
      data are available in the middle-east populations in general and Turkish patients in&#xD;
      particular, who have different etiology, ethnic, cultural backgrounds and risk factors from&#xD;
      those patients in the West. The aim of this study was to study Turkish patients with HFmrEF&#xD;
      and HFpEF, and define their clinical characteristics and the signs and symptoms of heart&#xD;
      failure, echocardiographic findings and medications at admission. With this national study,&#xD;
      we will evaluate how recommendations of most recent European guidelines regarding&#xD;
      pharmacological and non-pharmacological treatments are adopted in clinical practice. We will&#xD;
      also evaluate the prevalence of the clinical profiles of patients with HFmrEF and HFpEF,&#xD;
      according to the definitions proposed by the European Society of Cardiology, and to&#xD;
      investigate their appropriateness in characterizing patients with different clinical&#xD;
      presentations and needs.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      We have designed a prospective, multicentre, national, observational study to characterize&#xD;
      HFmrEF and HFpEF. Patients presented to cardiology outpatient clinics with signs and/or&#xD;
      symptoms of HFmrEF and HFpEF will be screened. The eligibility criteria included patients&#xD;
      older than 18 years with signs and/or symptoms of HF, admitted to public or private&#xD;
      hospitals. Assessed outcomes included the causes of decompensation, use of medications, care&#xD;
      quality indicators.&#xD;
&#xD;
      Data:&#xD;
&#xD;
      Clinical data, including the medical history, cardiovascular risk factors, and associate&#xD;
      comorbidities, will be collected. The symptoms of patients will be graded according to NYHA&#xD;
      classification. Blood samples will be collected for analysis of NT-pro-BNP and /or BNP, and&#xD;
      complete laboratory investigations will performed as well. A 12-lead surface ECG will be&#xD;
      recorded at 25 mm/s speed. Interpretation will be performed by a skilled investigator, and&#xD;
      left ventricular hypertrophy (LVH) will considered according to Sokolow index.&#xD;
&#xD;
      Diastolic function parameters will be measured as follows: peak early diastolic filling (E)&#xD;
      and late diastolic filling (A) velocities, E/A ratio, E deceleration time, early diastolic&#xD;
      septal mitral annular velocity (e') (averaged from three cardiac cycles), and E/e' as an&#xD;
      index of LV filling pressure. Left atrial volume index was calculated from apical four-and&#xD;
      two-chamber views, using area - length formula. Diastolic dysfunction will be classified into&#xD;
      four grades according to 2009 ASE guidelines.&#xD;
&#xD;
      Conclusion:&#xD;
&#xD;
      A ComPrehensive, ObservationaL Registry of Heart FaiLure With Mid-range and Preserved&#xD;
      EjectiON Fraction (APOLLON) study aims to characterize baseline characteristics of patients&#xD;
      with HFmrEF and HFpEF in Turkey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2018</start_date>
  <completion_date type="Actual">May 20, 2018</completion_date>
  <primary_completion_date type="Actual">May 20, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>The prevalence and management strategies of heart failure with midrange ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) patients among participating cardiology outpatient clinics.</measure>
    <time_frame>Recruited and could be analysed at least 1065 patients after 3 months</time_frame>
    <description>Outcomes included the causes of decompensation, use of medications, care quality indicators.</description>
  </primary_outcome>
  <enrollment type="Actual">1065</enrollment>
  <condition>Heart Failure</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention is planned in our study.</intervention_name>
    <description>No intervention is planned in our study.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presented to cardiology outpatient clinics with signs and/or symptoms of HF will&#xD;
        be screened.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Presentation to the hospital with clinical signs and symptoms of HF, according to the&#xD;
             Framingham criteria.&#xD;
&#xD;
          2. Age≥ 18 years&#xD;
&#xD;
          3. BNP≥35 pg/ml and/or NT-proBNP≥125 pg/ml&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. &lt;18 years old&#xD;
&#xD;
          3. LVEF &lt; %40&#xD;
&#xD;
          4. Cor pulmonale&#xD;
&#xD;
          5. Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial&#xD;
             constriction;&#xD;
&#xD;
          6. Primary hemodynamically significant uncorrected valvular heart disease, prosthetic&#xD;
             valve disease&#xD;
&#xD;
          7. Myocardial infarction in past 90 days&#xD;
&#xD;
          8. Coronary artery bypass graft surgery in past 90 days&#xD;
&#xD;
          9. Percutaneous coronary intervention in past 30 days;&#xD;
&#xD;
         10. Heart transplant recipient;&#xD;
&#xD;
         11. Currently implanted left ventricular assist device;&#xD;
&#xD;
         12. Stroke in past 90 days;&#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>BÜLENT ÖZLEK, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mugla Sitki Kocman University Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kahramanmaras Necip Fazıl City Hospital</name>
      <address>
        <city>Kahramanmaraş</city>
        <zip>46000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>June 13, 2018</last_update_submitted>
  <last_update_submitted_qc>June 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Muğla Sıtkı Koçman University</investigator_affiliation>
    <investigator_full_name>BÜLENT ÖZLEK</investigator_full_name>
    <investigator_title>Principal 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>
  <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/NCT03026114
org study id: MuglaSKU
nct id: NCT03026114
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%),
      termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or
      preserved ejection fraction (HFpEF, EF ≥ 50%).

      Up to now, there are no large scale studies evaluating patients with HFmrEF and/or HFpEF in
      Turkey. Scarce data are available in the middle-east populations in general and Turkish
      patients in particular, who have different etiology, ethnic, cultural backgrounds and risk
      factors from those patients in the West. The aim of this study was to study Turkish patients
      with HFmrEF and HFpEF, and define their clinical characteristics and the signs and symptoms
      of heart failure, echocardiographic findings and medications at admission. With this national
      study, we will evaluate how recommendations of most recent European guidelines regarding
      pharmacological and non-pharmacological treatments are adopted in clinical practice. We will
      also evaluate the prevalence of the clinical profiles of patients with HFmrEF and HFpEF,
      according to the definitions proposed by the European Society of Cardiology, and to
      investigate their appropriateness in characterizing patients with different clinical
      presentations and needs.

      Assessed outcomes included the causes of decompensation, use of medications, care quality
      indicators.
Purpose:

      To describe the demographic, clinical, and echocardiographic characteristics and management
      of outpatients heart failure (HF) with midrange ejection fraction (HFmrEF) and heart failure
      with preserved ejection fraction (HFpEF) followed by a representative setting of cardiology
      centres.

      Background:

      About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%),
      termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or
      preserved ejection fraction (HFpEF, EF ≥ 50%). Presentation and pathophysiology of HFmrEF and
      HFpEF is heterogeneous and its management remains a challenge since evidence of therapeutic
      benefits on outcome is scarce. Up to now, there are no large scale studies evaluating
      patients with HFmrEF and/or HFpEF in Turkey.

      Objective:

      Several studies have been conducted in western countries differentiating features of
      epidemiology, treatment, and outcomes among patients with preserved and reduced EF. Scarce
      data are available in the middle-east populations in general and Turkish patients in
      particular, who have different etiology, ethnic, cultural backgrounds and risk factors from
      those patients in the West. The aim of this study was to study Turkish patients with HFmrEF
      and HFpEF, and define their clinical characteristics and the signs and symptoms of heart
      failure, echocardiographic findings and medications at admission. With this national study,
      we will evaluate how recommendations of most recent European guidelines regarding
      pharmacological and non-pharmacological treatments are adopted in clinical practice. We will
      also evaluate the prevalence of the clinical profiles of patients with HFmrEF and HFpEF,
      according to the definitions proposed by the European Society of Cardiology, and to
      investigate their appropriateness in characterizing patients with different clinical
      presentations and needs.

      Methods:

      We have designed a prospective, multicentre, national, observational study to characterize
      HFmrEF and HFpEF. Patients presented to cardiology outpatient clinics with signs and/or
      symptoms of HFmrEF and HFpEF will be screened. The eligibility criteria included patients
      older than 18 years with signs and/or symptoms of HF, admitted to public or private
      hospitals. Assessed outcomes included the causes of decompensation, use of medications, care
      quality indicators.

      Data:

      Clinical data, including the medical history, cardiovascular risk factors, and associate
      comorbidities, will be collected. The symptoms of patients will be graded according to NYHA
      classification. Blood samples will be collected for analysis of NT-pro-BNP and /or BNP, and
      complete laboratory investigations will performed as well. A 12-lead surface ECG will be
      recorded at 25 mm/s speed. Interpretation will be performed by a skilled investigator, and
      left ventricular hypertrophy (LVH) will considered according to Sokolow index.

      Diastolic function parameters will be measured as follows: peak early diastolic filling (E)
      and late diastolic filling (A) velocities, E/A ratio, E deceleration time, early diastolic
      septal mitral annular velocity (e') (averaged from three cardiac cycles), and E/e' as an
      index of LV filling pressure. Left atrial volume index was calculated from apical four-and
      two-chamber views, using area - length formula. Diastolic dysfunction will be classified into
      four grades according to 2009 ASE guidelines.

      Conclusion:

      A ComPrehensive, ObservationaL Registry of Heart FaiLure With Mid-range and Preserved
      EjectiON Fraction (APOLLON) study aims to characterize baseline characteristics of patients
      with HFmrEF and HFpEF in Turkey.
observational model: Case-Only
time perspective: Prospective
measure: The prevalence and management strategies of heart failure with midrange ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) patients among participating cardiology outpatient clinics.
time frame: Recruited and could be analysed at least 1065 patients after 3 months
description: Outcomes included the causes of decompensation, use of medications, care quality indicators.
intervention type: Other
intervention name: No intervention is planned in our study.
description: No intervention is planned in our study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: BÜLENT ÖZLEK, M.D.
role: Principal Investigator
affiliation: Mugla Sitki Kocman University Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Muğla Sıtkı Koçman University
investigator full name: BÜLENT ÖZLEK
investigator title: Principal Investigator
mesh term: Heart Failure
sharing ipd: No