PEARL Study(PITAVASTATIN HEART FAILURE Study)

UMIN ID: C000000428

Registered date:09/06/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic heart failure
• Date of first enrollment: 2006/06/01
• Target sample size: 470
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Pitavastatin group
Control group

Outcome(s)

• Primary Outcome: Cardiac death or hospitalization due to worsening CHF.
• Secondary Outcome: Total mortality Cardiac death Hospitalization due to worsening CHF Acute myocardial infarction or unstable angina pectoris Cerebral stroke Undergo percutaneous coronary intervention Surgical therapy for worsening CHF Composite of above

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients who had already treated with statin. 2)Patients who will undertake changes of alternative treatment of CHF. 3) Myocardial infarction occurred within three months. 4) CABG or PCI performed within three months, or planning them. 5) Patients with active malignant tumor. 6) Patients with severe renal and hepatic dysfunction. 7) Patients with collagen disease. 8) Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period. 9) Patients whose consent is not obtained from themselves in written form. 10) Other patients judged as being inappropriate for the subjects of the study by investigators.

Related Information

• Primary Sponsor: Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine
• Secondary Sponsor: Saga University Faculty of Medicine Department of Cardiovascular & Renal Medicine and other institutes
• Source(s) of Monetary Support: None