Diastolic Heart Failure
Conditions
Keywords
Diastolic Heart Failure, Heart failure with preserved ejection fraction, nifedipine
Brief summary
Patients with heart failure with preserved ejection fraction have a equally high risk for mortality and re-hospitalization as those with reduced ejection fraction. Effective management strategies are critically needed to be established for this type of heart failure. These patients have more hypertensive and ischemic etiology than those with reduced ejection fraction. The investigators hypothesis is that Ca channel blocker nifedipine can improve the heart failure clinical composite response endpoint compared with the conventional treatment in patients with heart failure with hypertension and/or coronary artery disease and preserved ejection fraction (\>=50%) by echocardiography. This study is multi-center, prospective, randomized, open-label, and blinded-endpoint design.
Interventions
DRUGConventional therapy plus nifedipine
Participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014
DRUGConventional therapy
Conventional therapy
Sponsors
Demand Investigators
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 20 years and older 2. Heart failure with history of hypertension and/or coronary artery disease 3. LVEF \> or = 50% on echocardiography
Exclusion criteria
1. Valvular heart diseases with significant regurgitation and/or stenosis 2. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and active myocarditis 3. Constrictive pericarditis 4. Cardiogenic shock 5. Planned coronary artery bypass grafting or percutaneous coronary intervention within 3 months 6. History of acute coronary syndrome or stroke within 3 months 7. Pregnancy or breastfeeding 8. Hypersensitivity or contraindication to nifedipine 9. Inability to obtain informed consent 10. Any conditions not suitable for the participation in this trial judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heart failure clinical composite response endpoint | up to 53 months |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular death | up to 53 months |
| Hospital admission | up to 53 months |
| Hospital admission for cardiovascular disease | up to 53 months |
| Death | up to 53 months |
| Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention | up to 53 months |
| Stroke | up to 53 months |
| Hospital admission for worsening heart failure | up to 53 months |
Countries
Japan
Outcome results
None listed