Chronic Heart Failure
Conditions
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.
Interventions
DRUGolmesartan medoxomil
5 to 40mg P.O. daily until the end of the study
Sponsors
Tohoku University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| hospital admission from any cardiovascular reasons | by the end of the study | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. |
| cardiovascular death | by the end of the study | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. |
| death due to heart failure | by the end of the study | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. |
| sudden death | by the end of the study | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. |
| acute myocardial infarction | by the end of the study | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. |
| stroke | by the end of the study | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. |
| new-onset diabetes | by the end of the study | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. |
| development of renal failure | by the end of the study | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. |
| new-onset atrial fibrillation | by the end of the study | 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 | by the end of the study | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. |
| left ventricular ejection fraction | by the end of the study | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. |
| B-type natriuretic peptide | by the end of the study | All the patients were enrolled by March, 2010, and were followed-up by the end of March, 2013. |
| fatal arrhythmia or appropriate ICD discharge | 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
| Measure | Time frame | Description |
|---|---|---|
| serum markers for metabolic syndrome | 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 . |
Countries
Japan
Outcome results
None listed