Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan

Phase 3

Completed

• Conditions: Chronic Heart Failure
• Interventions: Drug: olmesartan medoxomil

• Registration Number: NCT00417222
• Lead Sponsor: Tohoku University

Brief Summary

The purpose of this study is to investigate whether an angiotensin II receptor blocker (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity in hypertensive patients with stable chronic heart failure.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-12-28
• Study First Submitted QC: 2006-12-28
• Study First Posted: 2006-12-29
• Primary Completion: 2013-03
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1145

Inclusion Criteria

Patients who meet all of the following criteria.

• Patients with NYHA class II through IV chronic heart failure.
• Patients who have a history of hypertension or those who have antihypertensive medications.
• Patients who are aged 20 years or older and less than 80 years at the entry.
• Stable patients who have angiotensin converting enzyme inhibitor and/or beta-blocker.
• Patients who do not have angiotensin II receptor blocker.

Exclusion Criteria

• Patients who have renal dysfunction (serum creatinine >=3.0mg/dL) or those who are receiving chronic hemodialysis.
• History of drug hypersensitivity to olmesartan.
• Patients who have severe liver dysfunction.
• History of angioedema.
• History of malignant tumor or life-threatening illness of poor prognosis.
• Pregnant or possibly pregnant patients.
• Cardiovascular surgery within 6months prior to the date of the entry.
• Acute myocardial infarction within 6 months prior to the date of the entry.
• Percutaneous coronary intervention or stent implantation within 6 months prior to the date of the entry.
• Other patients deemed unsuitable as subjects of the study by the treating physician.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olmesartan medoxomil	olmesartan medoxomil	olmesartan medoxomil

Primary Outcome Measures

Name	Time	Method
A composite of the following outcomes 1) all-cause death 2) nonfatal acute myocardial infarction 3) nonfatal stroke 4) hospital admission due to congestive heart failure	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

Secondary Outcome Measures

Name	Time	Method
new-onset diabetes	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
cardiovascular death	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
death due to heart failure	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
sudden death	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
acute myocardial infarction	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
stroke	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
hospital admission from any cardiovascular reasons	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
fatal arrhythmia or appropriate ICD discharge	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
development of renal failure	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
new-onset atrial fibrillation	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
a need to modify treatment procedures for heart failure	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
left ventricular ejection fraction	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
B-type natriuretic peptide	by the end of the study	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

Trial Locations

Locations (1)

Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine; 🇯🇵 Sendai-city, Japan