Diastolic Heart Failure Management by Nifedipine (DEMAND)

January 21, 2016 updated by: Demand Investigators
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Sapporo, Japan, 060-8638
        • Hokkaido Univestity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional therapy
Drug: Conventional therapy
Conventional therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Heart failure clinical composite response endpoint
Time Frame: up to 53 months
up to 53 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: up to 53 months
up to 53 months
Cardiovascular death
Time Frame: up to 53 months
up to 53 months
Hospital admission
Time Frame: up to 53 months
up to 53 months
Hospital admission for cardiovascular disease
Time Frame: up to 53 months
up to 53 months
Hospital admission for worsening heart failure
Time Frame: up to 53 months
up to 53 months
Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention
Time Frame: up to 53 months
up to 53 months
Stroke
Time Frame: up to 53 months
up to 53 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Demand Investigators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 1, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (Estimate)

July 7, 2010

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEMAND-01
  • UMIN000003856 (Other Identifier: University hospital Medical Information Network)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diastolic Heart Failure

Clinical Trials on Conventional therapy plus nifedipine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe