Overview

This trial is active, not recruiting.

Condition diastolic heart failure
Treatments conventional therapy plus nifedipine, conventional therapy
Sponsor Demand Investigators
Start date July 2010
End date December 2016
Trial size 226 participants
Trial identifier NCT01157481, DEMAND-01, UMIN000003856

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
conventional therapy plus nifedipine
Participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014
(Active Comparator)
conventional therapy
Conventional therapy

Primary Outcomes

Measure
Heart failure clinical composite response endpoint
time frame: up to 53 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Diastolic Heart Failure Management by Nifedipine
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Demand Investigators.