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

Sponsor:	Heart Care Foundation
Information provided by:	Heart Care Foundation
ClinicalTrials.gov Identifier:	NCT00403910

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Drug: Canrenone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic
Official Title:	Phase 3 Study Of Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Aldosterone Canrenone

U.S. FDA Resources

Further study details as provided by Heart Care Foundation:

Primary Outcome Measures:

Changes in echocardiographic left ventricular diastolic volume

Secondary Outcome Measures:

Changes in left ventricular systolic volume
Changes in ejection fraction
Changes in NYHA class
cardiac mortality
hospitalization for cardiac causes
combination of cardiac mortality hospitalizations for cardiac causes

Estimated Enrollment:	500
Study Start Date:	September 2002
Estimated Study Completion Date:	July 2006

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403910

Locations

Italy
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
Milano, Italy
Ospedale Policlinico
Modena, Italy
Hepseria Hospital Modena SPA
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 Santo Spirito
Roma, Italy
Policlinico Luigi di Liegro
Roma, Italy
Ospedale Sant'Andrea
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

Sponsors and Collaborators

Heart Care Foundation

Investigators

Study Chair:

Alessandro Boccanelli, MD

Ospedale San Giovanni di Roma

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

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. Review. Italian.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Jun 17.

ClinicalTrials.gov Identifier:	NCT00403910 History of Changes
Other Study ID Numbers:	17
Study First Received:	November 24, 2006
Last Updated:	April 16, 2009
Health Authority:	Italy: Ministry of Health

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Canrenone
Aldosterone Antagonists

Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012