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

Cardiac Heart Failure Patients Clinical Trial

— THE COFFEE-IT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263962
• Other study ID #: 20170016069
• Status: Completed
• Phase: N/A
• First received: August 23, 2017
• Last updated: February 1, 2018
• Start date: July 13, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: February 2018
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: November 30, 2017
• Est. primary completion date: September 10, 2017
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Heart Failure Patients
• Heart Failure

Intervention

Drug:
• Canrenone
Evaluation of canrenone therapy in patients with CHF

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

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