Clinical Trial: Diastolic Heart Failure Management by Nifedipine
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Diastolic Heart Failure Management by Nifedipine
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 Summary:
Sponsor: Demand Investigators
Current Primary Outcome: Heart failure clinical composite response endpoint [ Time Frame: up to 53 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Demand Investigators
Dates:
Date Received: July 1, 2010
Date Started: July 2010
Date Completion: December 2016
Last Updated: January 21, 2016
Last Verified: January 2016
