Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure. AREA IN-CHF Study
- Conditions
- Heart Failure
- Registration Number
- NCT00403910
- Lead Sponsor
- Heart Care Foundation
- 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 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.
- Detailed Description
The protocol is sponsored by and independent organization and partially supported by Therabel
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes in echocardiographic left ventricular diastolic volume
- Secondary Outcome Measures
Name Time Method cardiac mortality hospitalization for cardiac causes Changes in left ventricular systolic volume Changes in ejection fraction Changes in NYHA class combination of cardiac mortality hospitalizations for cardiac causes
Trial Locations
- Locations (44)
Ospedale Sant'Andrea
🇮🇹Roma, Italy
Ospedale casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo (FG), Italy
Ospedale SS Annunziata
🇮🇹Sassari, Italy
Ospedale San Luca
🇮🇹Vallo Della Lucania (SA), Italy
Presidio GM Lancisi
🇮🇹Ancona, Italy
Ospedali Riuniti
🇮🇹Bergamo, Italy
Ospedale Santo Spirito
🇮🇹Roma, Italy
Az Ospedaliera Giuseppe Moscati
🇮🇹Avellino, Italy
Presidio Ospedaliero Moscati
🇮🇹Aversa (CE), Italy
Az Osp G Brotzu - S Michele
🇮🇹Cagliari, Italy
Ospedale Civile San Giuseppe
🇮🇹Empoli (FI), Italy
Ospedale Civile Dario Camberlingo
🇮🇹Francavilla Fontana (BR), Italy
Presidio Ospedaliero di Passirana
🇮🇹Passirana Rho (MI), Italy
Ospedale Monsignor Angelo R di Miccoli
🇮🇹Barletta (BA), Italy
Ospedale Santa Maria del Prato
🇮🇹Feltre, Italy
Ospedale della val di nievole
🇮🇹Pescia (PT), Italy
Ospedale Infermi
🇮🇹Rimini, Italy
Ospedale San Camillo
🇮🇹Roma, Italy
Cardiologia Tiarini Corticella
🇮🇹Bologna, Italy
Ospedale San Raffaele G Giglio
🇮🇹Cefalù (PA), Italy
Hepseria Hospital Modena SPA
🇮🇹Modena, Italy
Fondazione Evangelica Betania
🇮🇹Napoli, Italy
Policlinico Luigi di Liegro
🇮🇹Roma, Italy
Az Osp-Univ San Martino
🇮🇹Genova, Italy
Ospedale Policlinico
🇮🇹Modena, Italy
Ospedale Policlinico S Matteo IRCCS
🇮🇹Pavia, Italy
Azienda Ospedaliera di Perugia
🇮🇹Perugia, Italy
Az Osp San Giovanni di Dio e Ruggi d'Aragona
🇮🇹Salerno, Italy
Ospedale G Fra Cristoforo
🇮🇹San Bonifacio (VR), Italy
Ospedale Cardinale Panico
🇮🇹Tricase (LE), Italy
IRCCS Policlinico Multimedica
🇮🇹Sesto San Giovanni, Italy
Ospedale Generale Provinciale
🇮🇹Bolzano, Italy
Az Ospedaliera S Anna e S Sebastiano
🇮🇹Caserta, Italy
Ospedale Generale Provinciale Lotti
🇮🇹Pontedera (PT), Italy
Ospedale Fatebenefratelli
🇮🇹Milano, Italy
Ospedale Civile
🇮🇹Ragusa (RG), Italy
Ospedale V Cervello
🇮🇹Palermo, Italy
Azienda CREAS - IFC CNR San Cartaldo
🇮🇹Pisa, Italy
Presidio Ospedaliero di Saronno
🇮🇹Saronno, Italy
Ospedale San Bartolomeo
🇮🇹Sarzana (GE), Italy
Az Osp-Univ Ospdali Riuniti
🇮🇹Trieste, Italy
Fondazione S Maugeri Clinica del Lavoro
🇮🇹Telese Terme (BN), Italy
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Ospedali Civili Riuniti
🇮🇹Venezia, Italy