Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure. AREA IN-CHF Study
Phase 3 Study Of Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure
1 other identifier
interventional
500
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 heart-failure
Started Sep 2002
Typical duration for phase_3 heart-failure
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 24, 2006
CompletedFirst Posted
Study publicly available on registry
November 27, 2006
CompletedFebruary 3, 2021
April 1, 2009
November 24, 2006
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in echocardiographic left ventricular diastolic volume
Secondary Outcomes (6)
Changes in left ventricular systolic volume
Changes in ejection fraction
Changes in NYHA class
cardiac mortality
hospitalization for cardiac causes
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
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
Related Publications (5)
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.
PMID: 15945301BACKGROUNDde 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.
PMID: 21939839BACKGROUNDClemenza 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.
PMID: 28855452BACKGROUNDBoccanelli 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.
PMID: 19147459RESULTBoccanelli 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.
PMID: 17700397RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alessandro Boccanelli, MD
Ospedale San Giovanni di Roma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 24, 2006
First Posted
November 27, 2006
Study Start
September 1, 2002
Study Completion
July 1, 2006
Last Updated
February 3, 2021
Record last verified: 2009-04