Rationale and design of a study to evaluate effects of pitavastatin on Japanese patients with chronic heart failure: The pitavastatin heart failure study (PEARL study)
International Journal of Cardiology, 03/30/2012
Mizuma H et al. – The PEARL study will provide important data on the role of pitavastatin in the treatment of Japanese patients with mildly symptomatic heart failure.Methods
- 577 patients with chronic heart failure were enrolled.
- Authors used a prospective, randomized, open–label, and blinded–endpoint evaluation (PROBE) design.
- Patients aged 20–79years old with symptomatic (NYHA functional class II or III) heart failure and a left ventricular ejection fraction of ≤45% were randomly allocated to either receive pitavastatin (2mg/day) or not in addition to conventional therapy for heart failure by using the minimization method.
- Follow–up will be continued until March 2011.
- The primary endpoint is a composite of cardiac death and hospitalization for worsening heart failure.