Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT)
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ClinicalTrials.gov Identifier: NCT00417222 |
Recruitment Status :
Completed
First Posted : December 29, 2006
Last Update Posted : May 19, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Heart Failure | Drug: olmesartan medoxomil | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1145 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT Trial) |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Olmesartan medoxomil
olmesartan medoxomil
|
Drug: olmesartan medoxomil
5 to 40mg P.O. daily until the end of the study |
No Intervention: Standard therapy
Standard therapy
|
- 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 diabetes [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: by the end of the study ]All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
- serum markers for metabolic syndrome [ Time Frame: three years ]Blood sampling was performed at the time of and 3 years after randomization. Changes in serum levels of markers for metabolic syndrome (high sensitive C-reactive protein, adiponectin, microRNAs) were examined .

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Ages Eligible for Study: | 20 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417222
Japan | |
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine | |
Sendai-city, Japan, 980-8574 |
Study Chair: | Hiroaki Shimokawa, MD, PhD | Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine |
Responsible Party: | Hiroaki Shimokawa, MD, PhD, Professor, Tohoku University |
ClinicalTrials.gov Identifier: | NCT00417222 |
Other Study ID Numbers: |
2006-179 |
First Posted: | December 29, 2006 Key Record Dates |
Last Update Posted: | May 19, 2014 |
Last Verified: | May 2014 |
Heart Failure Heart Diseases Cardiovascular Diseases Olmesartan Olmesartan Medoxomil |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |