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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Canrenone
Sponsored by
Heart Care Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Presidio GM Lancisi
  • Az Ospedaliera Giuseppe Moscati
  • Presidio Ospedaliero Moscati
  • Ospedale Monsignor Angelo R di Miccoli
  • Ospedali Riuniti
  • Cardiologia Tiarini Corticella
  • Ospedale Generale Provinciale
  • Az Osp G Brotzu - S Michele
  • Az Ospedaliera S Anna e S Sebastiano
  • Ospedale San Raffaele G Giglio
  • Ospedale Civile San Giuseppe
  • Ospedale Santa Maria del Prato
  • Ospedale Civile Dario Camberlingo
  • Az Osp-Univ San Martino
  • Ospedale Civile
  • Ospedale Fatebenefratelli
  • Hepseria Hospital Modena SPA
  • Ospedale Policlinico
  • Fondazione Evangelica Betania
  • Ospedale V Cervello
  • Presidio Ospedaliero di Passirana
  • Ospedale Policlinico S Matteo IRCCS
  • Azienda Ospedaliera di Perugia
  • Ospedale della val di nievole
  • Azienda CREAS - IFC CNR San Cartaldo
  • Ospedale Generale Provinciale Lotti
  • Ospedale Civile
  • Ospedale Infermi
  • Ospedale San Camillo
  • Ospedale Sant'Andrea
  • Ospedale Santo Spirito
  • Policlinico Luigi di Liegro
  • Az Osp San Giovanni di Dio e Ruggi d'Aragona
  • Ospedale G Fra Cristoforo
  • Ospedale casa Sollievo della Sofferenza
  • Presidio Ospedaliero di Saronno
  • Ospedale San Bartolomeo
  • Ospedale SS Annunziata
  • IRCCS Policlinico Multimedica
  • Fondazione S Maugeri Clinica del Lavoro
  • Ospedale Cardinale Panico
  • Az Osp-Univ Ospdali Riuniti
  • Ospedale San Luca
  • Ospedale di Circolo e Fondazione Macchi
  • Ospedali Civili Riuniti

Outcomes

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

Full Information

First Posted
November 24, 2006
Last Updated
February 2, 2021
Sponsor
Heart Care Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00403910
Brief Title
Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure. AREA IN-CHF Study
Official Title
Phase 3 Study Of Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Heart Care Foundation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Canrenone
Primary Outcome Measure Information:
Title
Changes in echocardiographic left ventricular diastolic volume
Secondary Outcome Measure Information:
Title
Changes in left ventricular systolic volume
Title
Changes in ejection fraction
Title
Changes in NYHA class
Title
cardiac mortality
Title
hospitalization for cardiac causes
Title
combination of cardiac mortality hospitalizations for cardiac causes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Boccanelli, MD
Organizational Affiliation
Ospedale San Giovanni di Roma
Official's Role
Study Chair
Facility Information:
Facility Name
Presidio GM Lancisi
City
Ancona
Country
Italy
Facility Name
Az Ospedaliera Giuseppe Moscati
City
Avellino
Country
Italy
Facility Name
Presidio Ospedaliero Moscati
City
Aversa (CE)
Country
Italy
Facility Name
Ospedale Monsignor Angelo R di Miccoli
City
Barletta (BA)
Country
Italy
Facility Name
Ospedali Riuniti
City
Bergamo
Country
Italy
Facility Name
Cardiologia Tiarini Corticella
City
Bologna
Country
Italy
Facility Name
Ospedale Generale Provinciale
City
Bolzano
Country
Italy
Facility Name
Az Osp G Brotzu - S Michele
City
Cagliari
Country
Italy
Facility Name
Az Ospedaliera S Anna e S Sebastiano
City
Caserta
Country
Italy
Facility Name
Ospedale San Raffaele G Giglio
City
Cefalù (PA)
Country
Italy
Facility Name
Ospedale Civile San Giuseppe
City
Empoli (FI)
Country
Italy
Facility Name
Ospedale Santa Maria del Prato
City
Feltre
Country
Italy
Facility Name
Ospedale Civile Dario Camberlingo
City
Francavilla Fontana (BR)
Country
Italy
Facility Name
Az Osp-Univ San Martino
City
Genova
Country
Italy
Facility Name
Ospedale Civile
City
Ivrea
Country
Italy
Facility Name
Ospedale Fatebenefratelli
City
Milano
Country
Italy
Facility Name
Hepseria Hospital Modena SPA
City
Modena
Country
Italy
Facility Name
Ospedale Policlinico
City
Modena
Country
Italy
Facility Name
Fondazione Evangelica Betania
City
Napoli
Country
Italy
Facility Name
Ospedale V Cervello
City
Palermo
Country
Italy
Facility Name
Presidio Ospedaliero di Passirana
City
Passirana Rho (MI)
Country
Italy
Facility Name
Ospedale Policlinico S Matteo IRCCS
City
Pavia
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia
City
Perugia
Country
Italy
Facility Name
Ospedale della val di nievole
City
Pescia (PT)
Country
Italy
Facility Name
Azienda CREAS - IFC CNR San Cartaldo
City
Pisa
Country
Italy
Facility Name
Ospedale Generale Provinciale Lotti
City
Pontedera (PT)
Country
Italy
Facility Name
Ospedale Civile
City
Ragusa (RG)
Country
Italy
Facility Name
Ospedale Infermi
City
Rimini
Country
Italy
Facility Name
Ospedale San Camillo
City
Roma
Country
Italy
Facility Name
Ospedale Sant'Andrea
City
Roma
Country
Italy
Facility Name
Ospedale Santo Spirito
City
Roma
Country
Italy
Facility Name
Policlinico Luigi di Liegro
City
Roma
Country
Italy
Facility Name
Az Osp San Giovanni di Dio e Ruggi d'Aragona
City
Salerno
Country
Italy
Facility Name
Ospedale G Fra Cristoforo
City
San Bonifacio (VR)
Country
Italy
Facility Name
Ospedale casa Sollievo della Sofferenza
City
San Giovanni Rotondo (FG)
Country
Italy
Facility Name
Presidio Ospedaliero di Saronno
City
Saronno
Country
Italy
Facility Name
Ospedale San Bartolomeo
City
Sarzana (GE)
Country
Italy
Facility Name
Ospedale SS Annunziata
City
Sassari
Country
Italy
Facility Name
IRCCS Policlinico Multimedica
City
Sesto San Giovanni
Country
Italy
Facility Name
Fondazione S Maugeri Clinica del Lavoro
City
Telese Terme (BN)
Country
Italy
Facility Name
Ospedale Cardinale Panico
City
Tricase (LE)
Country
Italy
Facility Name
Az Osp-Univ Ospdali Riuniti
City
Trieste
Country
Italy
Facility Name
Ospedale San Luca
City
Vallo Della Lucania (SA)
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
Country
Italy
Facility Name
Ospedali Civili Riuniti
City
Venezia
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
15945301
Citation
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.
Results Reference
background
PubMed Identifier
21939839
Citation
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.
Results Reference
background
PubMed Identifier
28855452
Citation
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.
Results Reference
background
PubMed Identifier
19147459
Citation
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.
Results Reference
result
PubMed Identifier
17700397
Citation
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.
Results Reference
result

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

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