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

Recruitment Status : Completed

First Posted : June 13, 2006

Last Update Posted : August 14, 2015

Sponsor:

Information provided by (Responsible Party):

Gruppo di Ricerca GISSI

Tracking Information

First Submitted Date ^ICMJE

June 12, 2006

First Posted Date ^ICMJE

June 13, 2006

Last Update Posted Date

August 14, 2015

Study Start Date ^ICMJE

August 2002

Actual Primary Completion Date

April 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

 All-cause mortality at the end of follow-up period
All cause mortality or hospitalizations for any reason at the end of follow-up period
Since the trial is event driven, the follow-up period will be completed when 1252 deaths
(number needed to allow a reliable evaluation of the efficacy of tested drugs for both R1 and R2) will occur.

Change History

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

GISSI-HF- Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF

Official Title ^ICMJE

A Large Scale Clinical Trial Testing the Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic Congestive Heart Failure

Brief Summary

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

Detailed Description

The Protocol is sponsored by an independent organization and partially supported by: AstraZeneca, Società Prodotti antibiotici, Sigma Tau, Pfizer

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Drug: n-3 PUFA
1 g die per os
Drug: Rosuvastatin
10 mg die per os
Drug: Placebo
1 gram c. per os
Drug: Placebo
10 mg c. per os

Study Arms ^ICMJE

Experimental: 1
N-3PUFA

Intervention: Drug: n-3 PUFA
Placebo Comparator: 2
Intervention: Drug: Placebo
Experimental: 3
Rosuvastatin

Intervention: Drug: Rosuvastatin
Placebo Comparator: 4
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

6975

Original Enrollment ^ICMJE

7000

Actual Study Completion Date ^ICMJE

May 2008

Actual Primary Completion Date

April 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Italy, Switzerland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00336336

Other Study ID Numbers ^ICMJE

G105

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Gruppo di Ricerca GISSI

Study Sponsor ^ICMJE

Gruppo di Ricerca GISSI

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Luigi Tavazzi, MD	Policlinico San Matteo di Pavia
Study Chair:	Gianni Tognoni, MD	Consorzio Mario Negri Sud

PRS Account

Gruppo di Ricerca GISSI

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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