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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hiroaki Shimokawa, MD, PhD, Tohoku University
ClinicalTrials.gov Identifier:
NCT00417222
First received: December 28, 2006
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Chronic Heart Failure
Drug: olmesartan medoxomil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Tohoku University:

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 [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.


Secondary Outcome Measures:
  • cardiovascular death [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

  • death due to heart failure [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

  • sudden death [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

  • acute myocardial infarction [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

  • stroke [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

  • hospital admission from any cardiovascular reasons [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

  • fatal arrhythmia or appropriate ICD discharge [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

  • new-onset diabetes [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

  • development of renal failure [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

  • new-onset atrial fibrillation [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    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 [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

  • left ventricular ejection fraction [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.

  • B-type natriuretic peptide [ Time Frame: by the end of the study ] [ Designated as safety issue: No ]
    All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013.


Other Outcome Measures:
  • serum markers for metabolic syndrome [ Time Frame: three years ] [ Designated as safety issue: No ]
    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 .


Enrollment: 1145
Study Start Date: November 2006
Study Completion Date: December 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417222

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

Additional Information:
No publications provided

Responsible Party: Hiroaki Shimokawa, MD, PhD, Professor, Tohoku University
ClinicalTrials.gov Identifier: NCT00417222     History of Changes
Other Study ID Numbers: 2006-179
Study First Received: December 28, 2006
Last Updated: May 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Olmesartan medoxomil
Olmesartan
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014