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

Study Overview
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Brief Summary
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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.

Official Title
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Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT Trial)

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Drug: olmesartan medoxomil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Olmesartan medoxomil<br>olmesartan medoxomil | Drug: olmesartan medoxomil<br>* 5 to 40mg P.O. daily until the end of the study<br>|
| No Intervention: Standard therapy<br>Standard therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. | by the end of the study | 

Secondary Outcome Measures

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