CClinicalTrials.gg
Status unknownNCT01157481DEMANDUpdated Jan 25, 2016

Diastolic Heart Failure Management by Nifedipine

An interventional study of Conventional therapy plus nifedipine and Conventional therapy in Diastolic Heart Failure, sponsored by Demand Investigators. Status unknown at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-01-25.

Sponsored by Demand Investigators · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
226
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diastolic Heart Failure

Keywords

  • Diastolic Heart Failure
  • Heart failure with preserved ejection fraction
  • nifedipine
03

In context

Heart Failure

5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's enrollment of 226 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

This is the only study on the registry with Demand Investigators as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
226 participants (actual)

Study arms

  • Experimental
    Conventional therapy plus nifedipine

    Drug: Conventional therapy plus nifedipine

  • Active comparator
    Conventional therapy

    Drug: Conventional therapy

Interventions

  • DrugConventional therapy plus nifedipine

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

  • DrugConventional therapy

    Conventional therapy

06

What researchers measure

Primary outcomes

  1. Heart failure clinical composite response endpoint

    Time frame: up to 53 months

Secondary outcomes

  1. Death

    Time frame: up to 53 months

  2. Cardiovascular death

    Time frame: up to 53 months

  3. Hospital admission

    Time frame: up to 53 months

  4. Hospital admission for cardiovascular disease

    Time frame: up to 53 months

  5. Hospital admission for worsening heart failure

    Time frame: up to 53 months

  6. Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention

    Time frame: up to 53 months

  7. Stroke

    Time frame: up to 53 months

07

Study locations

1 site
  • Hokkaido Univestity Hospital
    Sapporo, 060-8638, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01157481
Lead sponsor
Demand Investigators
Responsible party
Sponsor
First posted
Jul 7, 2010
Start date
Jul 2010
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jan 25, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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