Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336336
Status:
COMPLETED
Last Update Posted:
2015-08-14
First Post:
2006-06-12
Brief Title:
GISSI-HF- Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF
Sponsor:
Gruppo di Ricerca GISSI
Organization:
Gruppo di Ricerca GISSI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 managementoutcome 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None