Diastolic Heart Failure Management by Nifedipine

Not Applicable

• Conditions: Diastolic Heart Failure
• Interventions: Drug: Conventional therapy; Drug: Conventional therapy plus nifedipine

• Registration Number: NCT01157481
• Lead Sponsor: Demand Investigators

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-01-25
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional therapy	Conventional therapy	-
Conventional therapy plus nifedipine	Conventional therapy plus nifedipine	-

Primary Outcome Measures

Name	Time	Method
Heart failure clinical composite response endpoint	up to 53 months

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	up to 53 months
Death	up to 53 months
Hospital admission	up to 53 months
Hospital admission for cardiovascular disease	up to 53 months
Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention	up to 53 months
Hospital admission for worsening heart failure	up to 53 months
Stroke	up to 53 months

Trial Locations

Locations (1)

Hokkaido Univestity Hospital; 🇯🇵 Sapporo, Japan