Back to resultsDiastolic Heart Failure Management by Nifedipine (DEMAND)
Primary Purpose
Diastolic Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Conventional therapy plus nifedipine
Conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diastolic Heart Failure focused on measuring Diastolic Heart Failure, Heart failure with preserved ejection fraction, nifedipine
Eligibility Criteria
Inclusion Criteria:
- 20 years and older
- Heart failure with history of hypertension and/or coronary artery disease
- LVEF > or = 50% on echocardiography
Exclusion Criteria:
- Valvular heart diseases with significant regurgitation and/or stenosis
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and active myocarditis
- Constrictive pericarditis
- Cardiogenic shock
- Planned coronary artery bypass grafting or percutaneous coronary intervention within 3 months
- History of acute coronary syndrome or stroke within 3 months
- Pregnancy or breastfeeding
- Hypersensitivity or contraindication to nifedipine
- Inability to obtain informed consent
- Any conditions not suitable for the participation in this trial judged by the investigator
Sites / Locations
- Hokkaido Univestity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Conventional therapy plus nifedipine
Conventional therapy
Arm Description
Outcomes
Primary Outcome Measures
Heart failure clinical composite response endpoint
Secondary Outcome Measures
Death
Cardiovascular death
Hospital admission
Hospital admission for cardiovascular disease
Hospital admission for worsening heart failure
Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention
Stroke
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01157481
Brief Title
Diastolic Heart Failure Management by Nifedipine
Acronym
DEMAND
Official Title
Diastolic Heart Failure Management by Nifedipine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Demand Investigators
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure
Keywords
Diastolic Heart Failure, Heart failure with preserved ejection fraction, nifedipine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional therapy plus nifedipine
Arm Type
Experimental
Arm Title
Conventional therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Conventional therapy plus nifedipine
Intervention Description
Participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014
Intervention Type
Drug
Intervention Name(s)
Conventional therapy
Intervention Description
Conventional therapy
Primary Outcome Measure Information:
Title
Heart failure clinical composite response endpoint
Time Frame
up to 53 months
Secondary Outcome Measure Information:
Title
Death
Time Frame
up to 53 months
Title
Cardiovascular death
Time Frame
up to 53 months
Title
Hospital admission
Time Frame
up to 53 months
Title
Hospital admission for cardiovascular disease
Time Frame
up to 53 months
Title
Hospital admission for worsening heart failure
Time Frame
up to 53 months
Title
Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention
Time Frame
up to 53 months
Title
Stroke
Time Frame
up to 53 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20 years and older
Heart failure with history of hypertension and/or coronary artery disease
LVEF > or = 50% on echocardiography
Exclusion Criteria:
Valvular heart diseases with significant regurgitation and/or stenosis
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and active myocarditis
Constrictive pericarditis
Cardiogenic shock
Planned coronary artery bypass grafting or percutaneous coronary intervention within 3 months
History of acute coronary syndrome or stroke within 3 months
Pregnancy or breastfeeding
Hypersensitivity or contraindication to nifedipine
Inability to obtain informed consent
Any conditions not suitable for the participation in this trial judged by the investigator
Facility Information:
Facility Name
Hokkaido Univestity Hospital
City
Sapporo
ZIP/Postal Code
060-8638
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Diastolic Heart Failure Management by Nifedipine
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