Diastolic Heart Failure Management by Nifedipine

NCT ID: NCT01157481

Last Updated: 2016-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diastolic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional therapy plus nifedipine

Group Type EXPERIMENTAL

Conventional therapy plus nifedipine

Intervention Type DRUG

Participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014

Conventional therapy

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type DRUG

Conventional therapy

Interventions

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Conventional therapy plus nifedipine

Participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014

Intervention Type DRUG

Conventional therapy

Conventional therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Demand Investigators

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hokkaido Univestity Hospital

Sapporo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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UMIN000003856

Identifier Type: OTHER

Identifier Source: secondary_id

DEMAND-01

Identifier Type: -

Identifier Source: org_study_id

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