Diastolic Heart Failure Management by Nifedipine
DEMAND
2 other identifiers
interventional
226
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedFirst Posted
Study publicly available on registry
July 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 25, 2016
January 1, 2016
6.4 years
July 1, 2010
January 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart failure clinical composite response endpoint
up to 53 months
Secondary Outcomes (7)
Death
up to 53 months
Cardiovascular death
up to 53 months
Hospital admission
up to 53 months
Hospital admission for cardiovascular disease
up to 53 months
Hospital admission for worsening heart failure
up to 53 months
- +2 more secondary outcomes
Study Arms (2)
Conventional therapy plus nifedipine
EXPERIMENTALConventional therapy
ACTIVE COMPARATORInterventions
Participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014
Eligibility Criteria
You may qualify if:
- years and older
- Heart failure with history of hypertension and/or coronary artery disease
- LVEF \> or = 50% on echocardiography
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hokkaido Univestity Hospital
Sapporo, 060-8638, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2010
First Posted
July 7, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 25, 2016
Record last verified: 2016-01