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

Chronic Heart Failure Clinical Trial

— SUPPORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417222
• Other study ID #: 2006-179
• Status: Completed
• Phase: Phase 3
• First received: December 28, 2006
• Last updated: May 16, 2014
• Start date: November 2006
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Tohoku University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1145
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• olmesartan medoxomil
5 to 40mg P.O. daily until the end of the study

Locations

Country	Name	City	State
Japan	Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine	Sendai-city

Sponsors (1)

Lead Sponsor	Collaborator
Tohoku University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Click here for more information about this study: SUPPORT Trial