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

NCT ID: NCT00403910

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2006-07-31

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Interventions

Canrenone

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart Care Foundation

OTHER

Sponsor Role: lead

Principal Investigators

Alessandro Boccanelli, MD

Role: STUDY_CHAIR

Ospedale San Giovanni di Roma

Locations

Presidio GM Lancisi

Ancona, , Italy

Az Ospedaliera Giuseppe Moscati

Avellino, , Italy

Presidio Ospedaliero Moscati

Aversa (CE), , Italy

Ospedale Monsignor Angelo R di Miccoli

Barletta (BA), , Italy

Ospedali Riuniti

Bergamo, , Italy

Cardiologia Tiarini Corticella

Bologna, , Italy

Ospedale Generale Provinciale

Bolzano, , Italy

Az Osp G Brotzu - S Michele

Cagliari, , Italy

Az Ospedaliera S Anna e S Sebastiano

Caserta, , Italy

Ospedale San Raffaele G Giglio

Cefalù (PA), , Italy

Ospedale Civile San Giuseppe

Empoli (FI), , Italy

Ospedale Santa Maria del Prato

Feltre, , Italy

Ospedale Civile Dario Camberlingo

Francavilla Fontana (BR), , Italy

Az Osp-Univ San Martino

Genova, , Italy

Ospedale Civile

Ivrea, , Italy

Ospedale Fatebenefratelli

Milan, , Italy

Hepseria Hospital Modena SPA

Modena, , Italy

Ospedale Policlinico

Modena, , Italy

Fondazione Evangelica Betania

Napoli, , Italy

Ospedale V Cervello

Palermo, , Italy

Presidio Ospedaliero di Passirana

Passirana Rho (MI), , Italy

Ospedale Policlinico S Matteo IRCCS

Pavia, , Italy

Azienda Ospedaliera di Perugia

Perugia, , Italy

Ospedale della val di nievole

Pescia (PT), , Italy

Azienda CREAS - IFC CNR San Cartaldo

Pisa, , Italy

Ospedale Generale Provinciale Lotti

Pontedera (PT), , Italy

Ospedale Civile

Ragusa (RG), , Italy

Ospedale Infermi

Rimini, , Italy

Ospedale San Camillo

Roma, , Italy

Ospedale Sant'Andrea

Roma, , Italy

Ospedale Santo Spirito

Roma, , Italy

Policlinico Luigi di Liegro

Roma, , Italy

Az Osp San Giovanni di Dio e Ruggi d'Aragona

Salerno, , Italy

Ospedale G Fra Cristoforo

San Bonifacio (VR), , Italy

Ospedale casa Sollievo della Sofferenza

San Giovanni Rotondo (FG), , Italy

Presidio Ospedaliero di Saronno

Saronno, , Italy

Ospedale San Bartolomeo

Sarzana (GE), , Italy

Ospedale SS Annunziata

Sassari, , Italy

IRCCS Policlinico Multimedica

Sesto San Giovanni, , Italy

Fondazione S Maugeri Clinica del Lavoro

Telese Terme (BN), , Italy

Ospedale Cardinale Panico

Tricase (LE), , Italy

Az Osp-Univ Ospdali Riuniti

Trieste, , Italy

Ospedale San Luca

Vallo Della Lucania (SA), , Italy

Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Ospedali Civili Riuniti

Venezia, , Italy

Countries

Italy

References

Cacciatore G, Boccanelli A, Mureddu GF, Maggioni AP, Latini R, Masson S, de Simone G; Investigatori dell' Area In-CHF. [The AREA IN-CHF trial (antiremodeling effect of aldosterone receptors blockade with canrenone in mild chronic heart failure): rationale and design]. Ital Heart J. 2005 May;6 Suppl 1:66S-74S. Italian.

Reference Type: BACKGROUND

PMID: 15945301 (View on PubMed)

de Simone G, Chinali M, Mureddu GF, Cacciatore G, Lucci D, Latini R, Masson S, Vanasia M, Maggioni AP, Boccanelli A; AREA-in-CHF Investigators. Effect of canrenone on left ventricular mechanics in patients with mild systolic heart failure and metabolic syndrome: the AREA-in-CHF study. Nutr Metab Cardiovasc Dis. 2011 Oct;21(10):783-91. doi: 10.1016/j.numecd.2010.02.012. Epub 2010 Jun 17.

Reference Type: BACKGROUND

PMID: 21939839 (View on PubMed)

Clemenza F, Masson S, Conaldi PG, Di Carlo D, Boccanelli A, Mureddu GF, Gonzini L, Lucci D, Maggioni AP, Di Lenarda A, Nicolis EB, Vanasia M, Latini R; AREA IN-CHF Investigators. Galectin-3 and the Mineralocorticoid Receptor Antagonist Canrenone in Mild Heart Failure. Circ J. 2017 Sep 25;81(10):1543-1546. doi: 10.1253/circj.CJ-17-0656. Epub 2017 Aug 31.

Reference Type: BACKGROUND

PMID: 28855452 (View on PubMed)

Boccanelli A, Mureddu GF, Cacciatore G, Clemenza F, Di Lenarda A, Gavazzi A, Porcu M, Latini R, Lucci D, Maggioni AP, Masson S, Vanasia M, de Simone G; AREA IN-CHF Investigators. Anti-remodelling effect of canrenone in patients with mild chronic heart failure (AREA IN-CHF study): final results. Eur J Heart Fail. 2009 Jan;11(1):68-76. doi: 10.1093/eurjhf/hfn015.

Reference Type: RESULT

PMID: 19147459 (View on PubMed)

Boccanelli A, Cacciatore G, Mureddu GF, de Simone G, Clemenza F, De Maria R, Di Lenarda A, Gavazzi A, Latini R, Masson S, Porcu M, Vanasia M, Gonzini L, Maggioni AP. Baseline characteristics of patients recruited in the AREA IN-CHF study (Antiremodelling Effect of Aldosterone Receptors Blockade with Canrenone in Mild Chronic Heart Failure). J Cardiovasc Med (Hagerstown). 2007 Sep;8(9):683-91. doi: 10.2459/JCM.0b013e3281053a9a.

Reference Type: RESULT

PMID: 17700397 (View on PubMed)

Other Identifiers

17

Identifier Type: -

Identifier Source: org_study_id