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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Drug: olmesartan medoxomil

• Study Type: Interventional
• Enrollment (Actual): 1145
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Sendai-city, Japan, 980-8574
    • Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	by the end of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiovascular death	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study
death due to heart failure	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study
sudden death	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study
acute myocardial infarction	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study
stroke	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study
hospital admission from any cardiovascular reasons	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study
fatal arrhythmia or appropriate ICD discharge	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study
new-onset diabetes	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study
development of renal failure	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study
new-onset atrial fibrillation	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study
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.	by the end of the study
left ventricular ejection fraction	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study
B-type natriuretic peptide	All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.	by the end of the study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum markers for metabolic syndrome	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 .	three years

Collaborators and Investigators

• Sponsor: Tohoku University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 28, 2006
• First Submitted That Met QC Criteria: December 28, 2006
• First Posted (Estimate): December 29, 2006

Study Record Updates

• Last Update Posted (Estimate): May 19, 2014
• Last Update Submitted That Met QC Criteria: May 16, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Olmesartan; Olmesartan Medoxomil
• Other Study ID Numbers: 2006-179