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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03263962

Acronym

THE COFFEE-IT

Enrollment

502

Registered

2017-08-28

Start date

2017-07-13

Completion date

2017-11-30

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Heart Failure Patients

Keywords

CHF, Canrenone

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.

Interventions

DRUGCanrenone

Evaluation of canrenone therapy in patients with CHF

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Progression of CHF	12 years	Echocardiografic 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)
Cardiovascular mortality	12 years	Register data
Survival	12 years	Register data

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026