Diastolic Heart Failure Management by Nifedipine (DEMAND)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Demand Investigators
Sponsor:
Information provided by:
Demand Investigators
ClinicalTrials.gov Identifier:
NCT01157481
First received: July 1, 2010
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Diastolic Heart Failure
Drug: Conventional therapy plus nifedipine
Drug: Conventional therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diastolic Heart Failure Management by Nifedipine

Resource links provided by NLM:


Further study details as provided by Demand Investigators:

Primary Outcome Measures:
  • Heart failure clinical composite response endpoint [ Time Frame: up to 53 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death [ Time Frame: up to 53 months ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: up to 53 months ] [ Designated as safety issue: No ]
  • Hospital admission [ Time Frame: up to 53 months ] [ Designated as safety issue: No ]
  • Hospital admission for cardiovascular disease [ Time Frame: up to 53 months ] [ Designated as safety issue: No ]
  • Hospital admission for worsening heart failure [ Time Frame: up to 53 months ] [ Designated as safety issue: No ]
  • Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention [ Time Frame: up to 53 months ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: up to 53 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional therapy plus nifedipine Drug: 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 Drug: Conventional therapy
Conventional therapy

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157481

Locations
Japan
Hokkaido Univestity Hospital Recruiting
Sapporo, Japan, 060-8638
Contact: Daisuke Goto, M.D.       gotodsk@med.hokudai.ac.jp   
Sponsors and Collaborators
Demand Investigators
  More Information

No publications provided

Responsible Party: Hiroyuki Tsutsui/professor, Hokkaido University Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01157481     History of Changes
Other Study ID Numbers: DEMAND-01, UMIN000003856
Study First Received: July 1, 2010
Last Updated: June 22, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Demand Investigators:
Diastolic Heart Failure
Heart failure with preserved ejection fraction
nifedipine

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014