Diastolic Heart Failure Management by Nifedipine

Condition(s) targeted: Diastolic Heart Failure

Intervention: Conventional therapy plus nifedipine (Drug); Conventional therapy (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Demand Investigators

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.

Official title: Diastolic Heart Failure Management by Nifedipine

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

Primary outcome: Heart failure clinical composite response endpoint

Secondary outcome:

Death

Cardiovascular death

Hospital admission

Hospital admission for cardiovascular disease

Hospital admission for worsening heart failure

Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention

Stroke

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Hokkaido Univestity Hospital, Sapporo 060-8638, Japan; Recruiting
Daisuke Goto, M.D., Email: gotodsk@med.hokudai.ac.jp

Starting date: July 2010
Last updated: June 22, 2011