Diastolic Heart Failure Management by Nifedipine (DEMAND)

Demand Investigators

Status: Unknown

Conditions: Diastolic Heart Failure

Treatments: Drug: Conventional therapy plus nifedipine; Drug: Conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01157481

UMIN000003856 (Other Identifier)

DEMAND-01

Details and patient eligibility

About

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.

Enrollment: 226 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Conventional therapy plus nifedipine

Experimental group

Treatment:

Drug: Conventional therapy plus nifedipine

Conventional therapy

Active Comparator group

Treatment:

Drug: Conventional therapy