<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/NCT02976350</url>
  </required_header>
  <id_info>
    <org_study_id>HormoneHFpEF001</org_study_id>
    <nct_id>NCT02976350</nct_id>
  </id_info>
  <brief_title>Hormone Deficiency in Heart Failure With Preserved Ejection Fraction</brief_title>
  <acronym>MHDS in HFpEF</acronym>
  <official_title>Multiple Hormone Deficiency Syndrome in Heart Failure With Preserved Ejection Fraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in&#xD;
      Heart Failure with preserved Ejection Fraction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the effectiveness of the neurohormonal model to explain the progression of heart&#xD;
      failure and the many insights that it provided for the development of new therapies, there is&#xD;
      increasing clinical evidence that suggests that our current models fail to completely explain&#xD;
      the disease progression. Thus, neurohormonal models may be necessary but not sufficient to&#xD;
      explain all aspects of disease progression in the failing heart. There is evidence suggesting&#xD;
      that in heart failure there is a metabolic imbalance characterized by the predominance of the&#xD;
      catabolic status over the anabolic drive.&#xD;
&#xD;
      Consistent data coming from several independent groups have documented the reduced activity&#xD;
      of most anabolic axes in HF with reduced ejection fraction. To date, no study has addressed&#xD;
      the prevalence the presence and the prevalence of the Multiple Hormone Deficiencies in Heart&#xD;
      Failure with preserved Ejection Fraction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Prevalence of Hormone deficiency</measure>
    <time_frame>1 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Heart Failure</condition>
  <condition>Hormone Deficiencies</condition>
  <arm_group>
    <arm_group_label>Patients with HFpEF</arm_group_label>
    <description>Male patients with heart failure with preserved ejection fraction</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum for determination of hormonal levels&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Male patients with stable chronic heart failure with preserved ejection fraction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patients of affected by CHF, secondary to ischemic or idiopathic dilated&#xD;
             cardiomyopathy&#xD;
&#xD;
          -  left ventricle ejection fraction &gt; 50% or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe liver disease&#xD;
&#xD;
          -  serum creatinine levels &gt;2.5 mg/dl&#xD;
&#xD;
          -  history of active cancer with life expectancy below 1 year acute coronary syndrome in&#xD;
             the previous 6 months&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Cittadini, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Federico II University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Antonio Cittadini</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>May 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Antonio Cittadini</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Heart failure</keyword>
  <keyword>Heart failure with preserved ejection fraction</keyword>
  <keyword>GH deficiency</keyword>
  <keyword>Testosterone deficiency</keyword>
  <keyword>Low- T3 syndrome</keyword>
  <keyword>Multiple Hormone Deficiencies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Endocrine System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02976350
org study id: HormoneHFpEF001
nct id: NCT02976350
lead sponsor: 
has dmc: Yes
The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in
      Heart Failure with preserved Ejection Fraction.
Despite the effectiveness of the neurohormonal model to explain the progression of heart
      failure and the many insights that it provided for the development of new therapies, there is
      increasing clinical evidence that suggests that our current models fail to completely explain
      the disease progression. Thus, neurohormonal models may be necessary but not sufficient to
      explain all aspects of disease progression in the failing heart. There is evidence suggesting
      that in heart failure there is a metabolic imbalance characterized by the predominance of the
      catabolic status over the anabolic drive.

      Consistent data coming from several independent groups have documented the reduced activity
      of most anabolic axes in HF with reduced ejection fraction. To date, no study has addressed
      the prevalence the presence and the prevalence of the Multiple Hormone Deficiencies in Heart
      Failure with preserved Ejection Fraction.
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of Hormone deficiency
time frame: 1 months
arm group label: Patients with HFpEF
description: Male patients with heart failure with preserved ejection fraction
serum for determination of hormonal levels
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonio Cittadini, Professor
role: Study Chair
affiliation: Federico II University
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Antonio Cittadini
investigator title: Clinical Professor
mesh term: Heart Failure
mesh term: Endocrine System Diseases
sharing ipd: Yes