Back to resultsSupplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT)
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
olmesartan medoxomil
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure
Eligibility 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.
Sites / Locations
- Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Olmesartan medoxomil
Standard therapy
Arm Description
olmesartan medoxomil
Standard therapy
Outcomes
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
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Secondary Outcome Measures
cardiovascular death
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
death due to heart failure
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
sudden death
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
acute myocardial infarction
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
stroke
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
hospital admission from any cardiovascular reasons
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
fatal arrhythmia or appropriate ICD discharge
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
new-onset diabetes
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
development of renal failure
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
new-onset atrial fibrillation
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
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
left ventricular ejection fraction
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
B-type natriuretic peptide
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00417222
Brief Title
Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan
Acronym
SUPPORT
Official Title
Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tohoku University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olmesartan medoxomil
Arm Type
Active Comparator
Arm Description
olmesartan medoxomil
Arm Title
Standard therapy
Arm Type
No Intervention
Arm Description
Standard therapy
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Intervention Description
5 to 40mg P.O. daily until the end of the study
Primary Outcome Measure Information:
Title
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
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Secondary Outcome Measure Information:
Title
cardiovascular death
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
death due to heart failure
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
sudden death
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
acute myocardial infarction
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
stroke
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
hospital admission from any cardiovascular reasons
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
fatal arrhythmia or appropriate ICD discharge
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
new-onset diabetes
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
development of renal failure
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
new-onset atrial fibrillation
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
a need to modify treatment procedures for heart failure
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
left ventricular ejection fraction
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Title
B-type natriuretic peptide
Description
All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.
Time Frame
by the end of the study
Other Pre-specified Outcome Measures:
Title
serum markers for metabolic syndrome
Description
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 .
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Shimokawa, MD, PhD
Organizational Affiliation
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
City
Sendai-city
ZIP/Postal Code
980-8574
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25637937
Citation
Sakata Y, Shiba N, Takahashi J, Miyata S, Nochioka K, Miura M, Takada T, Saga C, Shinozaki T, Sugi M, Nakagawa M, Sekiguchi N, Komaru T, Kato A, Fukuchi M, Nozaki E, Hiramoto T, Inoue K, Goto T, Ohe M, Tamaki K, Ibayashi S, Ishide N, Maruyama Y, Tsuji I, Shimokawa H; SUPPORT Trial Investigators; SUPPORT Trial Investigators. Clinical impacts of additive use of olmesartan in hypertensive patients with chronic heart failure: the supplemental benefit of an angiotensin receptor blocker in hypertensive patients with stable heart failure using olmesartan (SUPPORT) trial. Eur Heart J. 2015 Apr 14;36(15):915-23. doi: 10.1093/eurheartj/ehu504. Epub 2015 Jan 30.
Results Reference
derived
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Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan
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