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Sponsored by: |
Gruppo di Ricerca GISSI |
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Information provided by: | Gruppo di Ricerca GISSI |
ClinicalTrials.gov Identifier: | NCT00336336 |
INTRODUCTION While pharmacological treatments specifically targeted to the cardio-circulatory system have been largely investigated, scanty controlled data are available concerning the role of dietary and metabolic approaches in the management/outcome of patients with heart failure. A large scale, randomized, clinical trial is proposed to test the effects of (a) n-3 PUFA and (b) a lipid lowering agent on top of the best recommended treatments for heart failure.
STUDY DESIGN
The GISSI-HF is a prospective, multicenter, randomized, double blind, placebo controlled study, with randomized allocation of patients with a clinical diagnosis of heart failure to:
Randomization 1 (R1): n-3 PUFA 1 g daily vs corresponding placebo; Randomization 2 (R2): rosuvastatin 10 mg daily vs corresponding placebo.
OBJECTIVES OF THE STUDY PRIMARY OBJECTIVES
To demonstrate that, in patients with heart failure treated at the best of recommended therapies, long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than the corresponding placebo in the reduction of:
OTHER END-POINT MEASURES OF EFFICACY
To assess that long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than corresponding placebo in the reduction of:
Condition | Intervention | Phase |
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Heart Failure |
Drug: n-3 PUFA Drug: Rosuvastatin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Large Scale Clinical Trial Testing the Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic Congestive Heart Failure |
Enrollment: | 6975 |
Study Start Date: | August 2002 |
Study Completion Date: | May 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
N-3PUFA
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Drug: n-3 PUFA
1 g die per os
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2: Placebo Comparator |
Drug: Placebo
1 gram c. per os
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3: Experimental
Rosuvastatin
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Drug: Rosuvastatin
10 mg die per os
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4: Placebo Comparator |
Drug: Placebo
10 mg c. per os
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The Protocol is sponsored by an independent organization and partially supported by: AstraZeneca, Società Prodotti antibiotici, Sigma Tau, Pfizer
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
COMMON EXCLUSION CRITERIA (R1=n-3 PUFA vs placebo and R2=rosuvastatin vs placebo):
EXCLUSION CRITERIA FOR R2 (statin hypothesis):
Responsible Party: | Heart Care Foundation Onlus ( Aldo P. Maggioni ) |
Study ID Numbers: | G105 |
Study First Received: | June 12, 2006 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00336336 |
Health Authority: | Italy: Ministry of Health |
Heart Failure Rosuvastatin Heart Diseases |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |