<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/NCT03263962</url>
  </required_header>
  <id_info>
    <org_study_id>20170016069</org_study_id>
    <nct_id>NCT03263962</nct_id>
  </id_info>
  <brief_title>Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure (the Coffee-it Study)</brief_title>
  <acronym>THE COFFEE-IT</acronym>
  <official_title>Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure: the Coffee-it Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pavia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pavia</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>
      To evaluate canrenone effects compared to other therapies on cardiovascular mortality in&#xD;
      patients with congestive heart failure and preserved systolic function after 12 years of&#xD;
      evaluation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will verify patients with cardiac heart failure (CHF) and preserved&#xD;
      systolic function and each patient must have all clinical evaluation through basal&#xD;
      measurements of blood pressure, heart rate, biochemical tests, and color Doppler&#xD;
      echocardiographic parameters for at least 12 years.&#xD;
&#xD;
      The investigators will evaluate the effects of an aldosterone antagonist as canrenone&#xD;
      compared to a group without canrenone and the investogators will verify how many patients&#xD;
      reported cardiovascular mortality or will survive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2017</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 10, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Progression of CHF</measure>
    <time_frame>12 years</time_frame>
    <description>Echocardiografic data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Haemodynamic data</measure>
    <time_frame>12 years</time_frame>
    <description>Systolic blood pressure (SBP, Diastolic blood pressure (DBP), Heart rate (HR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic data</measure>
    <time_frame>12 years</time_frame>
    <description>fasting plasma glucose (FPG), total cholesterol (TC), HDL-cholesterol (HDL-C), triglycerides (Tg), LDL-cholesterol (LDL-C), lipoprotein (a) [Lp(a)],</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal function</measure>
    <time_frame>12 years</time_frame>
    <description>Sodium, Potassium, Creatinine, Uric acid</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endocrine data</measure>
    <time_frame>12 years</time_frame>
    <description>Aldosterone, Plasma brain natriuretic peptide (BNP), Plasma renin activity (PRA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular mortality</measure>
    <time_frame>12 years</time_frame>
    <description>Register data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>12 years</time_frame>
    <description>Register data</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">502</enrollment>
  <condition>Cardiac Heart Failure Patients</condition>
  <arm_group>
    <arm_group_label>With canrenone</arm_group_label>
    <description>Patients with canrenone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without canrenone</arm_group_label>
    <description>Patients without canrenone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Canrenone</intervention_name>
    <description>Evaluation of canrenone therapy in patients with CHF</description>
    <arm_group_label>With canrenone</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with CHF and preserved systolic function with or without an aldosterone antagonist&#xD;
        as canrenone.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with CHF&#xD;
&#xD;
          -  preserved systolic function (FE ≥ 45%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe hypertension identified by blood pressure ≥180/110 mmHg&#xD;
&#xD;
          -  patients with impaired systolic function (FE &lt; 45%)&#xD;
&#xD;
          -  history of active hepatitis or cirrhosis&#xD;
&#xD;
          -  impaired renal function&#xD;
&#xD;
          -  hyperpotassemia&#xD;
&#xD;
          -  diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>February 1, 2018</last_update_submitted>
  <last_update_submitted_qc>February 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pavia</investigator_affiliation>
    <investigator_full_name>Giuseppe Derosa</investigator_full_name>
    <investigator_title>MD, PhD, FESC</investigator_title>
  </responsible_party>
  <keyword>CHF</keyword>
  <keyword>Canrenone</keyword>
  <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>Canrenone</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/NCT03263962
org study id: 20170016069
nct id: NCT03263962
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate canrenone effects compared to other therapies on cardiovascular mortality in
      patients with congestive heart failure and preserved systolic function after 12 years of
      evaluation.
The investigators will verify patients with cardiac heart failure (CHF) and preserved
      systolic function and each patient must have all clinical evaluation through basal
      measurements of blood pressure, heart rate, biochemical tests, and color Doppler
      echocardiographic parameters for at least 12 years.

      The investigators will evaluate the effects of an aldosterone antagonist as canrenone
      compared to a group without canrenone and the investogators will verify how many patients
      reported cardiovascular mortality or will survive.
observational model: Cohort
time perspective: Retrospective
measure: Progression of CHF
time frame: 12 years
description: Echocardiografic data
measure: Haemodynamic data
time frame: 12 years
description: Systolic blood pressure (SBP, Diastolic blood pressure (DBP), Heart rate (HR)
measure: Metabolic data
time frame: 12 years
description: fasting plasma glucose (FPG), total cholesterol (TC), HDL-cholesterol (HDL-C), triglycerides (Tg), LDL-cholesterol (LDL-C), lipoprotein (a) [Lp(a)],
measure: Renal function
time frame: 12 years
description: Sodium, Potassium, Creatinine, Uric acid
measure: Endocrine data
time frame: 12 years
description: Aldosterone, Plasma brain natriuretic peptide (BNP), Plasma renin activity (PRA)
measure: Cardiovascular mortality
time frame: 12 years
description: Register data
measure: Survival
time frame: 12 years
description: Register data
arm group label: With canrenone
description: Patients with canrenone
arm group label: Without canrenone
description: Patients without canrenone
intervention type: Drug
intervention name: Canrenone
description: Evaluation of canrenone therapy in patients with CHF
arm group label: With canrenone
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Pavia
investigator full name: Giuseppe Derosa
investigator title: MD, PhD, FESC
mesh term: Heart Failure
mesh term: Canrenone
sharing ipd: No