Diastolic Heart Failure Management by Nifedipine

Last updated: January 21, 2016
Sponsor: Demand Investigators
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

N/A

Clinical Study ID

NCT01157481
DEMAND-01
UMIN000003856
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Valvular heart diseases with significant regurgitation and/or stenosis

  2. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic rightventricular cardiomyopathy, and active myocarditis

  3. Constrictive pericarditis

  4. Cardiogenic shock

  5. Planned coronary artery bypass grafting or percutaneous coronary intervention within 3months

  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 theinvestigator

Study Design

Total Participants: 226
Study Start date:
July 01, 2010
Estimated Completion Date:
December 31, 2016

Connect with a study center

  • Hokkaido Univestity Hospital

    Sapporo, 060-8638
    Japan

    Site Not Available

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