Clinical trial NCT00417222: Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan
Official title: Supplemental Benefit of Angiotensin II Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Heart Failure
Lead sponsor: Tohoku University
Sponsor class: OTHER
First posted: 2006-12-29
Enrollment: 1145
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: by the end of the study
Secondary outcomes:
measure: cardiovascular death
timeFrame: by the end of the study
measure: death due to heart failure
timeFrame: by the end of the study
measure: sudden death
timeFrame: by the end of the study
measure: acute myocardial infarction
timeFrame: by the end of the study
measure: stroke
timeFrame: by the end of the study
measure: hospital admission from any cardiovascular reasons
timeFrame: by the end of the study
measure: fatal arrhythmia or appropriate ICD discharge
timeFrame: by the end of the study
measure: new-onset diabetes
timeFrame: by the end of the study
measure: development of renal failure
timeFrame: by the end of the study
measure: new-onset atrial fibrillation
timeFrame: by the end of the study
measure: a need to modify treatment procedures for heart failure
timeFrame: by the end of the study
measure: left ventricular ejection fraction
timeFrame: by the end of the study
measure: B-type natriuretic peptide
timeFrame: by the end of the study
Other outcomes:
measure: serum markers for metabolic syndrome
timeFrame: three years
Locations:
city: Sendai-city
country: Japan
facility: Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Study officials:
affiliation: Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
name: Hiroaki Shimokawa, MD, PhD
role: STUDY_CHAIR
References:
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.