Status:
COMPLETED
Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure. AREA IN-CHF Study
Lead Sponsor:
Heart Care Foundation
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 favo...
Detailed Description
The protocol is sponsored by and independent organization and partially supported by Therabel
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00403910
Start Date
September 1 2002
End Date
July 1 2006
Last Update
February 3 2021
Active Locations (45)
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1
Presidio GM Lancisi
Ancona, Italy
2
Az Ospedaliera Giuseppe Moscati
Avellino, Italy
3
Presidio Ospedaliero Moscati
Aversa (CE), Italy
4
Ospedale Monsignor Angelo R di Miccoli
Barletta (BA), Italy