Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure. AREA IN-CHF Study

Heart Care Foundation

Status and phase

Completed

Phase 3

Conditions

Heart Failure

Treatments

Drug: Canrenone

Study type

Interventional

Funder types

Other

Identifiers

NCT00403910

Details and patient eligibility

About

The RALES study has shown that spironolactone reduces the risk of morbidity and mortality both from progressive heart failure and sudden death, in patients with NYHA III or IV heart failure. This favourable effect was clearly independent from a diuretic effect. Antialdosterone drugs may be effective because they opposes the effects of aldosterone on sodium retention, loss of magnesium and potassium, sympathetic activation, baroreceptor function and vascular compliance. Antialdosterone treatment may also antagonize the effect of aldosterone in promoting cardiac fibrosis. In a RALES substudy baseline serum PIIINP, a marker of cardiac fibrosis synthesis showed an independent negative correlation with survival and CHF hospitalizations in the placebo group. Therefore it seems interesting to evaluate the effect of an Aldosterone receptor blocker on progression of left ventricular dysfunction in patients with mild heart failure assuming standard therapy.

Full description

The protocol is sponsored by and independent organization and partially supported by Therabel

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Established diagnosis of congestive heart failure in NYHA class II
Left ventricular ejection fraction <= 45% measured within 6 months from enrolment
Stable standard heart failure therapy (if patients are on beta blocker drugs, treatment must have been started at least three months before enrolment)
Informed consent (obtained prior of any study procedures)

Exclusion criteria

Age <18 and >80
Serum creatinine level > 2.5 mg per deciliter
Serum potassium level > 5.0 mmol per liter
Valvular heart disease amenable to surgical treatment
Congenital heart disease
Unstable angina and/or acute myocardial infarction and/or coronary revascularization procedure within three months before enrolment
Intravenous therapy with inotropic drugs within three months before enrolment
History of resuscitated ventricular fibrillation or tachycardia, unless these occurred within 24 hours of an acute myocardial infarction or the subject has an implanted an automatic cardioverter defibrillator
Chronic active hepatitis or cirrhosis
Malignant neoplasm or any life threatening non cardiac disease
History of hypersensitivity to study drug
Pregnancy or lactating or childbearing age women who are not protected by an accepted method of contraception
History of drug or alcohol abuse
Legal incapacity and/or other circumstances rending the patient unable to understand the nature, scope and possible consequences of the study.
Evidence of uncooperative attitude
Any condition other than heart failure that does not permit an optimal participation to the trial
Participation to other RCTs during the last 3 months
Treatment with: Lithium salts, Potassium sparing diuretics, oral positive inotropic drugs or any investigational drug