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

This study has been completed.
Sponsor:
Information provided by:
Heart Care Foundation
ClinicalTrials.gov Identifier:
NCT00403910
First received: November 24, 2006
Last updated: April 16, 2009
Last verified: April 2009
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014