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

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.

Results

  • The primary endpoint is a composite of cardiac death and hospitalization for worsening heart failure.

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