Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan (SUPPORT)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Chronic Heart Failure	Drug: olmesartan medoxomil	Phase 3

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.

Other Outcome Measures:

1. 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 .

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:	All
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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Click here for more information about this study: SUPPORT Trial 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Hiroaki Shimokawa, MD, PhD, Professor, Tohoku University
ClinicalTrials.gov Identifier:	NCT00417222 History of Changes
Other Study ID Numbers:	2006-179
First Posted:	December 29, 2006
Last Update Posted:	May 19, 2014
Last Verified:	May 2014

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