Diastolic Heart Failure Management by Nifedipine

Study Overview
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Brief Summary
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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
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Diastolic Heart Failure Management by Nifedipine

Conditions
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Diastolic Heart Failure

Intervention / Treatment
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* Drug: Conventional therapy plus nifedipine
* Drug: Conventional therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional therapy plus nifedipine<br> | Drug: Conventional therapy plus nifedipine<br>* Participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014<br>|
| Active Comparator: Conventional therapy<br> | Drug: Conventional therapy<br>* Conventional therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure clinical composite response endpoint |  | up to 53 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | up to 53 months | 
| Cardiovascular death |  | up to 53 months | 
| Hospital admission |  | up to 53 months | 
| Hospital admission for cardiovascular disease |  | up to 53 months | 
| Hospital admission for worsening heart failure |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diastolic Heart Failure, Heart failure with preserved ejection fraction, nifedipine