GISSI-HF- Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF
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| ClinicalTrials.gov Identifier: NCT00336336 |
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Recruitment Status :
Completed
First Posted : June 13, 2006
Last Update Posted : August 14, 2015
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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:
- All-cause mortality
- All-cause mortality or hospitalizations for cardiovascular reason
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:
- Cardiovascular mortality
- Cardiovascular mortality or hospitalizations for any reason
- Sudden cardiac death
- Hospitalizations for any reason
- Hospitalizations for cardiovascular reasons
- Hospitalizations for congestive heart failure
- Myocardial infarction
- Stroke
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure | Drug: n-3 PUFA Drug: Rosuvastatin Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 6975 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | August 2002 |
| Actual Primary Completion Date : | April 2008 |
| Actual Study Completion Date : | May 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
N-3PUFA
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Drug: n-3 PUFA
1 g die per os |
| Placebo Comparator: 2 |
Drug: Placebo
1 gram c. per os |
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Experimental: 3
Rosuvastatin
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Drug: Rosuvastatin
10 mg die per os |
| Placebo Comparator: 4 |
Drug: Placebo
10 mg c. per os |
- All-cause mortality [ Time Frame: from enrollment to 1252 deaths in R2 arm ]
- All cause mortality or hospitalizations for any reason [ Time Frame: from enrollment to 1252 deaths ]
- Cardiovascular mortality [ Time Frame: from enrollment to 1252 deaths in R2 arm ]
- Cardiovascular mortality or hospitalization for heart failure or for any reasons [ Time Frame: from enrollment to 1252 deaths in R2 arm ]
- Sudden cardiac death [ Time Frame: from enrollment to 1252 deaths in R2 arm ]
- Hospitalizations for any reasons [ Time Frame: from enrollment to 1252 deaths in R2 arm ]
- Hospitalization for Cardiovascular reasons [ Time Frame: from enrollment to 1252 deaths in R2 arm ]
- Hospitalization for congestive heart failure [ Time Frame: from enrollment to 1252 deaths in R2 arm ]
- Miocardial infarction [ Time Frame: from enrollment to 1252 deaths in R2 arm ]
- Stroke [ Time Frame: from enrollment to 1252 deaths in R2 arm ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical evidence of heart failure according to the European Society of Cardiology guidelines (New York Heart Association class II-IV) (32)
- Any left ventricular Ejection Fraction (EF) measured within 3 months from enrolment (if EF% >40%, at least 1 hospital admission for Congestive Heart Failure(CHF) in the previous year)
- No age limits
- Any etiology
- Informed consent (obtained before any study specific procedure)
Exclusion Criteria:
COMMON EXCLUSION CRITERIA (R1=n-3 PUFA vs placebo and R2=rosuvastatin vs placebo):
- Acute Myocardial Infarction, unstable angina or revascularization procedure within 1 month;
- planned cardiac surgery, expected to be performed within 3 months;
- congenital or primary valvular etiology;
- known hypersensitivity to study treatments;
- significant liver disease;
- pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception;
- any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol;
- presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy;
- treatment with any investigational agent within 1 month before randomization;
- patients already on treatment with n-3 PUFA or statin for whom the prescription is confirmed.
EXCLUSION CRITERIA FOR R2 (statin hypothesis):
- current serum creatinine level >2.5 mg/dL;
- current ALT, AST level >1.5 times the upper normal limit;
- current CPK upper normal limits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336336
Show 337 Study Locations
| Study Chair: | Luigi Tavazzi, MD | Policlinico San Matteo di Pavia | |
| Study Chair: | Gianni Tognoni, MD | Consorzio Mario Negri Sud |
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gruppo di Ricerca GISSI |
| ClinicalTrials.gov Identifier: | NCT00336336 History of Changes |
| Other Study ID Numbers: |
G105 |
| First Posted: | June 13, 2006 Key Record Dates |
| Last Update Posted: | August 14, 2015 |
| Last Verified: | September 2010 |
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Heart Failure Heart Diseases Cardiovascular Diseases Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |