Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure. AREA IN-CHF Study
This study has been completed.
Sponsor:
Heart Care Foundation
Information provided by:
Heart Care Foundation
ClinicalTrials.gov Identifier:
NCT00403910
First received: November 24, 2006
Last updated: April 16, 2009
Last verified: April 2009
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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 |
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:
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 Aldosterone Antagonists |
Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013