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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Heart Failure Patients
• Intervention / Treatment: Drug: Canrenone

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 Type: Observational
• Enrollment (Actual): 502

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • IRCCS Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with CHF and preserved systolic function with or without an aldosterone antagonist as canrenone.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With canrenone; Patients with canrenone	Drug: Canrenone; Evaluation of canrenone therapy in patients with CHF
Without canrenone; Patients without canrenone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of CHF	Echocardiografic data	12 years
Haemodynamic data	Systolic blood pressure (SBP, Diastolic blood pressure (DBP), Heart rate (HR)	12 years
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
Renal function	Sodium, Potassium, Creatinine, Uric acid	12 years
Endocrine data	Aldosterone, Plasma brain natriuretic peptide (BNP), Plasma renin activity (PRA)	12 years
Cardiovascular mortality	Register data	12 years
Survival	Register data	12 years

Collaborators and Investigators

• Sponsor: University of Pavia

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2017
• Primary Completion (ACTUAL): September 10, 2017
• Study Completion (ACTUAL): November 30, 2017

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (ACTUAL): August 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: CHF; Canrenone
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Diuretics; Hormone Antagonists; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Canrenone
• Other Study ID Numbers: 20170016069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No