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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
 (submitted: May 30, 2008)
  • 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
 (submitted: June 12, 2006)
  •  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 Complete list of historical versions of study NCT00336336 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
  • 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
 (submitted: May 30, 2008)
6975
Original Enrollment  ICMJE
 (submitted: June 12, 2006)
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 No
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