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| 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: | Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Phase 3 Study Of Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Ospedale Civile | |
| Ivrea, Italy | |
| Ospedale di Circolo e Fondazione Macchi | |
| Varese, Italy | |
| Presidio Ospedaliero di Saronno | |
| Saronno, Italy | |
| Ospedale Fatebenefratelli | |
| Milano, Italy | |
| Ospedali Riuniti | |
| Bergamo, Italy | |
| Ospedale Policlinico S Matteo IRCCS | |
| Pavia, Italy | |
| IRCCS Policlinico Multimedica | |
| Sesto San Giovanni, Italy | |
| Presidio Ospedaliero di Passirana | |
| Passirana Rho (MI), Italy | |
| Ospedale Generale Provinciale | |
| Bolzano, Italy | |
| Ospedale G Fra Cristoforo | |
| San Bonifacio (VR), Italy | |
| Ospedale Santa Maria del Prato | |
| Feltre, Italy | |
| Ospedali Civili Riuniti | |
| Venezia, Italy | |
| Az Osp-Univ Ospdali Riuniti | |
| Trieste, Italy | |
| Az Osp-Univ San Martino | |
| Genova, Italy | |
| Ospedale San Bartolomeo | |
| Sarzana (GE), Italy | |
| Ospedale Policlinico | |
| Modena, Italy | |
| Ospedale Infermi | |
| Rimini, Italy | |
| Hepseria Hospital Modena SPA | |
| Modena, Italy | |
| Cardiologia Tiarini Corticella | |
| Bologna, Italy | |
| Ospedale della val di nievole | |
| pescia (PT), Italy | |
| Ospedale Generale Provinciale Lotti | |
| Pontedera (PT), Italy | |
| Ospedale Civile San Giuseppe | |
| Empoli (FI), Italy | |
| Azienda CREAS - IFC CNR San Cartaldo | |
| Pisa, Italy | |
| Az Osp G Brotzu - S Michele | |
| Cagliari, Italy | |
| Presidio GM Lancisi | |
| Ancona, Italy | |
| Ospedale San Camillo | |
| Roma, Italy | |
| Ospedale San Camillo | |
| Roma, Italy | |
| Ospedale Santo Spirito | |
| Roma, Italy | |
| Policlinico Luigi di Liegro | |
| Roma, Italy | |
| Ospedale Sant'Andrea | |
| Roma, Italy | |
| Az Ospedaliera S Anna e S Sebastiano | |
| Caserta, Italy | |
| Presidio Ospedaliero Moscati | |
| Aversa (CE), Italy | |
| Fondazione S Maugeri Clinica del Lavoro | |
| Telese Terme (BN), Italy | |
| Az Ospedaliera Giuseppe Moscati | |
| Avellino, Italy | |
| Az Osp San Giovanni di Dio e Ruggi d'Aragona | |
| Salerno, Italy | |
| Ospedale San Luca | |
| Vallo della Lucania (SA), Italy | |
| Fondazione Evangelica Betania | |
| Napoli, Italy | |
| Ospedale Monsignor Angelo R di Miccoli | |
| Barletta (BA), Italy | |
| Ospedale Civile Dario Camberlingo | |
| Francavilla Fontana (BR), Italy | |
| Ospedale casa Sollievo della Sofferenza | |
| San Giovanni Rotondo (FG), Italy | |
| Ospedale Cardinale Panico | |
| Tricase (LE), Italy | |
| Ospedale Civile | |
| Ragusa (RG), Italy | |
| Ospedale San Raffaele G Giglio | |
| Cefalù (PA), Italy | |
| Ospedale V Cervello | |
| Palermo, Italy | |
| Ospedale SS Annunziata | |
| Sassari, Italy | |
| Azienda Ospedaliera di Perugia | |
| Perugia, Italy | |
| Study Chair: | Alessandro Boccanelli, MD | Ospedale San Giovanni di Roma |
More Information
| Study ID Numbers: | 17 |
| Study First Received: | November 24, 2006 |
| Last Updated: | April 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00403910 History of Changes |
| Health Authority: | Italy: Ministry of Health |
|
Canrenone Heart Failure Heart Diseases Aldosterone Antagonists Hormone Antagonists |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Diseases Pharmacologic Actions |