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Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure (the Coffee-it Study) (THE COFFEE-IT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03263962
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Giuseppe Derosa, University of Pavia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiac Heart Failure Patients Drug: Canrenone

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 502 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure: the Coffee-it Study
Actual Study Start Date : July 13, 2017
Actual Primary Completion Date : September 10, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort Intervention/treatment
With canrenone
Patients with canrenone
 Drug: Canrenone
Evaluation of canrenone therapy in patients with CHF
Without canrenone
Patients without canrenone


Outcome Measures
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Primary Outcome Measures :
  1. Progression of CHF [ Time Frame: 12 years ]
    Echocardiografic data

  2. Haemodynamic data [ Time Frame: 12 years ]
    Systolic blood pressure (SBP, Diastolic blood pressure (DBP), Heart rate (HR)

  3. Metabolic data [ Time Frame: 12 years ]
    fasting plasma glucose (FPG), total cholesterol (TC), HDL-cholesterol (HDL-C), triglycerides (Tg), LDL-cholesterol (LDL-C), lipoprotein (a) [Lp(a)],

  4. Renal function [ Time Frame: 12 years ]
    Sodium, Potassium, Creatinine, Uric acid

  5. Endocrine data [ Time Frame: 12 years ]
    Aldosterone, Plasma brain natriuretic peptide (BNP), Plasma renin activity (PRA)

  6. Cardiovascular mortality [ Time Frame: 12 years ]
    Register data

  7. Survival [ Time Frame: 12 years ]
    Register data


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with CHF and preserved systolic function with or without an aldosterone antagonist as canrenone.
Criteria

Inclusion Criteria:

  • patients with CHF
  • preserved systolic function (FE ≥ 45%)

Exclusion Criteria:

  • severe hypertension identified by blood pressure ≥180/110 mmHg
  • patients with impaired systolic function (FE < 45%)
  • history of active hepatitis or cirrhosis
  • impaired renal function
  • hyperpotassemia
  • diabetes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263962


Locations
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Italy
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
University of Pavia
More Information
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Responsible Party: Giuseppe Derosa, MD, PhD, FESC, University of Pavia
ClinicalTrials.gov Identifier: NCT03263962    
Other Study ID Numbers: 20170016069
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giuseppe Derosa, University of Pavia:
CHF
Canrenone
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Canrenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents