We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diastolic Heart Failure Management by Nifedipine (DEMAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01157481
Recruitment Status : Unknown
Verified January 2016 by Demand Investigators.
Recruitment status was:  Active, not recruiting
First Posted : July 7, 2010
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Diastolic Heart Failure Drug: Conventional therapy plus nifedipine Drug: Conventional therapy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diastolic Heart Failure Management by Nifedipine
Study Start Date : July 2010
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Nifedipine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Heart failure clinical composite response endpoint [ Time Frame: up to 53 months ]

Secondary Outcome Measures :
  1. Death [ Time Frame: up to 53 months ]
  2. Cardiovascular death [ Time Frame: up to 53 months ]
  3. Hospital admission [ Time Frame: up to 53 months ]
  4. Hospital admission for cardiovascular disease [ Time Frame: up to 53 months ]
  5. Hospital admission for worsening heart failure [ Time Frame: up to 53 months ]
  6. Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention [ Time Frame: up to 53 months ]
  7. Stroke [ Time Frame: up to 53 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157481


Locations
Japan
Hokkaido Univestity Hospital
Sapporo, Japan, 060-8638
Sponsors and Collaborators
Demand Investigators

Responsible Party: Demand Investigators
ClinicalTrials.gov Identifier: NCT01157481     History of Changes
Other Study ID Numbers: DEMAND-01
UMIN000003856 ( Other Identifier: University hospital Medical Information Network )
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016

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
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs