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Completed

NCT Number: NCT03263962

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

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.

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Key information

Conditions

Cardiac Heart Failure Patients

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canrenone

Drug

Evaluation of canrenone therapy in patients with CHF

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure: the Coffee-it Study

Acronym: THE COFFEE-IT

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 28, 2017
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.