Authors
Gissi-HF Investigators
Title
Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial)
References
Lancet. 2008 Oct 4;372(9645):1231-9
Background
Large observational studies, small prospective studies and post-hoc analyses of randomised clinical trials have suggested that statins could be beneficial in patients with chronic heart failure.
Purpose
To determine the efficacy and safety of rosuvastatin in patients with symptomatic heart failure.
Design
  • Multicenter, randomized, double blinded placebo controlled trial
  • 2285 pts (rosuvastatin) 2289 pts (placebo), aged >18 years with symptomatic heart failure of any etiology (NYHA II-IV)
  • If LVEF >40%, then must have at least one hospital admission for HF in preceding year
Exclusion Criteria
  • ACS or revascularization within 1 month, planned cardiac surgery within 3 months
  • Any non-cardiac comorbidity likely leading to life expectancy <1 year
  • Significant liver dysfunction (AST/ALT > 1.5x ULN)
  • Elevated CK
  • Creatinine > 221umol/L
Follow-Up
Median 3.9 years (Interquartile Range 3.0-4.4)
Treatment Regimen
  • Rosuvastatin 10mg/day or placebo
  • Follow-up visits scheduled at 1, 3, 6, and 12 months and then 6 monthly thereafter. Compliance, lipid and routine blood work assessed at each visit.
Results

Primary Endpoints

Rosuvastatin
n=2285		 Placebo
n=2289		Hazard Ratiop
Cardiac death
29%28%1.00 (0.89-1.12)0.94
Death or hospital admission for cardiac reasons
57%56%1.01 (0.91-1.11)0.90

Secondary Outcomes

(see paper for complete list)

Rosuvastatin
n=2285		 Placebo
n=2289		Hazard Ratiop
Cardiac death
20.9%21.3%0.96 (0.85-1.09)0.55
Any stroke
3.6%2.9%1.23 (0.89-1.70)0.21
Any MI
2.7%3.1%0.89 (0.63-1.26)0.52
Summary
Rosuvastatin 10 mg daily did not affect clinical outcomes in patients with chronic heart failure of any cause, in whom the drug was safe.