Diastolic Heart FailureDEMANDNCT01157481
Diastolic Heart Failure Management by Nifedipine
A study testing Conventional therapy plus nifedipine and Conventional therapy in people with Diastolic Heart Failure, run by Demand Investigators at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diastolic Heart Failure
- What is being tested?
- Conventional therapy plus nifedipine and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2010to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years and older
- Heart failure with history of hypertension and/or coronary artery disease
- LVEF > or = 50% on echocardiography
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diastolic Heart Failure
- Being tested
- Conventional therapy plus nifedipine, Conventional therapy
- Keywords
- Diastolic Heart Failure, Heart failure with preserved ejection fraction, nifedipine
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapy plus nifedipineDrug
Participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014
Conventional therapy
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy plus nifedipine | Experimental | Not described Receives: Drug: Conventional therapy plus nifedipine |
| Conventional therapy | Active comparator | Not described Receives: Drug: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure clinical composite response endpoint
Measured: up to 53 months
Secondary outcomes (7)
Death
Measured: up to 53 months
Cardiovascular death
Measured: up to 53 months
Hospital admission
Measured: up to 53 months
Hospital admission for cardiovascular disease
Measured: up to 53 months
Hospital admission for worsening heart failure
Measured: up to 53 months
Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention
Measured: up to 53 months
Stroke
Measured: up to 53 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Demand Investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157481
- Sponsor's protocol ID
- DEMAND-01
- Other IDs
- UMIN000003856
- Acronym
- DEMAND
- Status last verified
- Jan 2016
- First submitted
- 1 Jul 2010
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Heart Failure Management by Nifedipine
- ClinicalTrials.gov ID
- NCT01157481
- Acronym / sponsor ID
- DEMAND / DEMAND-01
- Conditions
- Diastolic Heart Failure
- Keywords
- Diastolic Heart Failure, Heart failure with preserved ejection fraction, nifedipine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Demand InvestigatorsUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy plus nifedipine | Experimental | Drug: Conventional therapy plus nifedipine |
| Conventional therapy | Active comparator | Drug: Conventional therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 years and older
- Heart failure with history of hypertension and/or coronary artery disease
- LVEF > or = 50% on echocardiography
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional therapy plus nifedipineParticipants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014 | Drug | Conventional therapy plus nifedipine |
| Conventional therapyConventional therapy | Drug | Conventional therapy |
Primary outcome
Heart failure clinical composite response endpoint
Time frame: up to 53 months
7 secondary outcomes
Death
Time frame: up to 53 months
Cardiovascular death
Time frame: up to 53 months
Hospital admission
Time frame: up to 53 months
Hospital admission for cardiovascular disease
Time frame: up to 53 months
Hospital admission for worsening heart failure
Time frame: 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
Stroke
Time frame: up to 53 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional therapy plus nifedipine and Conventional therapy in people with Diastolic Heart Failure, run by Demand Investigators at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure clinical composite response endpoint (time frame: up to 53 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.