Supplemental Benefit of Angiotensin Receptor Blocker (ARB) in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT Trial)
This study is ongoing, but not recruiting participants.
Sponsor:
Tohoku University
Information provided by:
Tohoku University
ClinicalTrials.gov Identifier:
NCT00417222
First received: December 28, 2006
Last updated: March 31, 2010
Last verified: March 2010
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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: three years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- cardiovascular death [ Time Frame: three years ] [ Designated as safety issue: No ]
- death due to heart failure [ Time Frame: three years ] [ Designated as safety issue: No ]
- sudden death [ Time Frame: three years ] [ Designated as safety issue: No ]
- acute myocardial infarction [ Time Frame: three years ] [ Designated as safety issue: No ]
- stroke [ Time Frame: three years ] [ Designated as safety issue: No ]
- hospital admission from any cardiovascular reasons [ Time Frame: three years ] [ Designated as safety issue: No ]
- fatal arrhythmia or appropriate ICD discharge [ Time Frame: three years ] [ Designated as safety issue: No ]
- new-onset diabetes [ Time Frame: three years ] [ Designated as safety issue: No ]
- development of renal failure [ Time Frame: three years ] [ Designated as safety issue: No ]
- new-onset atrial fibrillation [ Time Frame: three years ] [ Designated as safety issue: No ]
- a need to modify treatment procedures for heart failure [ Time Frame: three years ] [ Designated as safety issue: No ]
- left ventricular ejection fraction [ Time Frame: three years ] [ Designated as safety issue: No ]
- B-type natriuretic peptide [ Time Frame: three years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | December 2013 |
| Estimated 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 |
| 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
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:
No publications provided
| Responsible Party: | Hiroaki Shimokawa, MD, Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00417222 History of Changes |
| Other Study ID Numbers: | 2006-179 |
| Study First Received: | December 28, 2006 |
| Last Updated: | March 31, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Olmesartan medoxomil Olmesartan Angiotensin Receptor Antagonists |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013