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

Completed

• Conditions: Cardiac Heart Failure Patients
• Interventions: Drug: Canrenone

• Registration Number: NCT03263962
• Lead Sponsor: University of Pavia

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.

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 Timeline

• Study Start: 2017-07-13
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-28
• Primary Completion: 2017-09-10
• Study Completion: 2017-11-30
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With canrenone	Canrenone	Patients with canrenone

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality	12 years	Register data
Survival	12 years	Register data
Haemodynamic data	12 years	Systolic blood pressure (SBP, Diastolic blood pressure (DBP), Heart rate (HR)
Metabolic data	12 years	fasting plasma glucose (FPG), total cholesterol (TC), HDL-cholesterol (HDL-C), triglycerides (Tg), LDL-cholesterol (LDL-C), lipoprotein (a) \[Lp(a)\],
Renal function	12 years	Sodium, Potassium, Creatinine, Uric acid
Endocrine data	12 years	Aldosterone, Plasma brain natriuretic peptide (BNP), Plasma renin activity (PRA)
Progression of CHF	12 years	Echocardiografic data

Trial Locations

Locations (1)

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy