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

University of Pavia

Status: Completed

Conditions: Cardiac Heart Failure Patients

Treatments: Drug: Canrenone

Study type: Observational

Funder types: Other

Identifiers

NCT03263962

20170016069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 502 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

502 participants in 2 patient groups

With canrenone

Description:

Patients with canrenone

Treatment:

Drug: Canrenone

Without canrenone

Description:

Patients without canrenone