Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients with Stable Heart Failure using Olmesartan

UMIN ID: UMIN000000561

Registered date:26/12/2006

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Chronic Heart Failure
• Date of first enrollment: 2006/11/01
• Target sample size: 1000
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Olmesartan 5-40mg daily, during the study period.
Control

Outcome(s)

• Primary Outcome: A composite of all-cause death, nonfatal acute myocardial infarction, nonfatal stroke, and hospital admission due to congestive heart failure.
• Secondary Outcome: Secondary outcomes 1)all-cause death 2)cardiovascular death 3)death due to heart failure 4)sudden death 5)acute myocardial infarction 6)stroke 7)hospital admission from any cardiovascular reasons Other outcomes 1)fatal arrhythmia or appropriate ICD discharge 2)new-onset diabetes 3)development of renal failure 4)new-onset atrial fibrillation 5)a need to modify treatment procedures for heart failure 6)left ventricular ejection fraction 7)BNP

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)Patients who have renal dysfunction (serum creatinine >=3.0mg/dL) or those who are receiving chronic hemodialysis. 2)History of drug hypersensitivity to olmesartan. 3)Patients who have severe liver dysfunction. 4)History of angioedema. 5)History of malignant tumor or life-threatening illness of poor prognosis. 6)Pregnant or possibly pregnant patients. 7)Cardiovascular surgery within 6months prior to the date of the entry. 8)Acute myocardial infarction within 6 months prior to the date of the entry. 9)Percutaneous coronary intervention or stent implantation within 6 months prior to the date of the entry. 10)Other patients deemed unsuitable as subjects of the study by the treating physician.

Related Information

• Primary Sponsor: Tohoku Heart Failure Association The SUPPORT Study Group
• Source(s) of Monetary Support: None