Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT)
This study has been completed.
Sponsor:
Tohoku University
Information provided by (Responsible Party):
Hiroaki Shimokawa, MD, PhD, Tohoku University
ClinicalTrials.gov Identifier:
NCT00417222
First received: December 28, 2006
Last updated: May 16, 2014
Last verified: May 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Heart Failure |
Drug: olmesartan medoxomil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by Tohoku University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Secondary Outcome Measures:
- cardiovascular death [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Other Outcome Measures:
- serum markers for metabolic syndrome [ Time Frame: three years ] [ Designated as safety issue: No ]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 .
| Enrollment: | 1145 |
| Study Start Date: | November 2006 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 20 Years to 79 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00417222
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417222
Locations
| Japan | |
| Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine | |
| Sendai-city, Japan, 980-8574 | |
Sponsors and Collaborators
Tohoku University
Investigators
| Study Chair: | Hiroaki Shimokawa, MD, PhD | Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hiroaki Shimokawa, MD, PhD, Professor, Tohoku University |
| ClinicalTrials.gov Identifier: | NCT00417222 History of Changes |
| Other Study ID Numbers: | 2006-179 |
| Study First Received: | December 28, 2006 |
| Last Updated: | May 16, 2014 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Olmesartan Olmesartan Medoxomil |
Angiotensin Receptor Antagonists Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 29, 2016