Diastolic Heart Failure Management by Nifedipine

Diastolic Heart Failure Clinical Trial

— DEMAND  

Official title:

Diastolic Heart Failure Management by Nifedipine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01157481
• Other study ID #: DEMAND-01
• Secondary ID: UMIN000003856
• Status: Active, not recruiting
• Phase: N/A
• First received: July 1, 2010
• Last updated: January 21, 2016
• Start date: July 2010
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Demand Investigators
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 226
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic

Intervention

Drug:
• Conventional therapy plus nifedipine
Participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014
• Conventional therapy
Conventional therapy

Locations

Country	Name	City	State
Japan	Hokkaido Univestity Hospital	Sapporo

Sponsors (1)

Lead Sponsor	Collaborator
Demand Investigators

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart failure clinical composite response endpoint		up to 53 months	No
Secondary	Death		up to 53 months	No
Secondary	Cardiovascular death		up to 53 months	No
Secondary	Hospital admission		up to 53 months	No
Secondary	Hospital admission for cardiovascular disease		up to 53 months	No
Secondary	Hospital admission for worsening heart failure		up to 53 months	No
Secondary	Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention		up to 53 months	No
Secondary	Stroke		up to 53 months	No