Trial | NCT01157481  Report issue

Official Title

Diastolic Heart Failure Management by Nifedipine

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    nifedipine ...

  • Study Participants

    226
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.
Study Started
Jul 31
2010
Primary Completion
Dec 31
2016
Anticipated
Study Completion
Dec 31
2016
Anticipated
Last Update
Jan 25
2016
Estimate

Drug Conventional therapy plus nifedipine

Participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014

Drug Conventional therapy

Conventional therapy

Conventional therapy plus nifedipine Experimental

Conventional therapy Active Comparator

Criteria 

Inclusion Criteria:

20 years and older
Heart failure with history of hypertension and/or coronary artery disease
LVEF > or = 50% on echocardiography

Exclusion Criteria:

Valvular heart diseases with significant regurgitation and/or stenosis
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and active myocarditis
Constrictive pericarditis
Cardiogenic shock
Planned coronary artery bypass grafting or percutaneous coronary intervention within 3 months
History of acute coronary syndrome or stroke within 3 months
Pregnancy or breastfeeding
Hypersensitivity or contraindication to nifedipine
Inability to obtain informed consent
Any conditions not suitable for the participation in this trial judged by the investigator
No Results Posted