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Completed

NCT Number: NCT00417222

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

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.

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Key information

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine

Sendai, 980-8574, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

olmesartan medoxomil

Drug

5 to 40mg P.O. daily until the end of the study

Primary outcomes

  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 outcomes

  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 outcomes

  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 .

Sponsors and collaborators

Lead sponsor

Tohoku University

Other

Registry information

Official study title

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

Acronym: SUPPORT

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Dec 29, 2006
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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