UMIN ID: UMIN000000561
Registered date:26/12/2006
Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients with Stable Heart Failure using Olmesartan
Basic Information
Recruitment status | Complete: follow-up continuing |
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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. |
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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 |
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Age maximum | 80years-old |
Gender | Male and Female |
Include criteria | |
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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Nobuyuki Shiba |
Address | 1-1, Seiryo-machi, Aoba-ku, Sendai-city Japan |
Telephone | 022-717-7153 |
nshiba@cardio.med.tohoku.ac.jp | |
Affiliation | Tohoku University Graduate School of Medicine Department of Cardiovascular Medicine |
scientific contact | |
Name | Hiroaki Shimokawa |
Address | 1-1, Seiryo-machi, Aoba-ku, Sendai-city Japan |
Telephone | 022-717-7153 |
Affiliation | Tohoku University Graduate School of Medicine Department of Cardiovascular Medicine |