UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003856 |
|---|---|
| Receipt number | R000004634 |
| Scientific Title | Diastolic Heart Failure Management by Nifedipine (DEMAND) |
| Date of disclosure of the study information | 2010/07/03 |
| Last modified on | 2018/12/28 11:57:52 |
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Basic information
Public title
Diastolic Heart Failure Management by Nifedipine (DEMAND)
Acronym
Diastolic Heart Failure Management by Nifedipine (DEMAND)
Scientific Title
Diastolic Heart Failure Management by Nifedipine (DEMAND)
Scientific Title:Acronym
Diastolic Heart Failure Management by Nifedipine (DEMAND)
Region
| Japan |
Condition
Condition
Diastolic Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to evaluate the effects of sustained-release nifedipine on the clinical composite response endpoint in patients with heart failure with preserved ejection fraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Heart failure clinical composite response endpoint
Key secondary outcomes
Death
Cardiovascular death
Hospital admission
Hospital admission for cardiovascular disease
Hospital admission for worsening heart failure
Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention
Stroke
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention
Conventional therapy plus nifedipine:
participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014
Interventions/Control_2
Control
Conventional therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Heart failure with history of hypertension and/or coronary artery disease
2) LVEF > or = 50% on echocardiography
3) Without taking nifedipine
4) 20 years and older
5) Inpatient and outpatient
6) Male and female
Key exclusion criteria
1) Valvular heart diseases with significant regurgitation and/or stenosis
2) Hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrythmogenic 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
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsutsui |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
011-706-6973
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nouvelle Place Inc.
Division name
DEMAND office
Zip code
Address
Yushima 1-6-3, Bunkyouku-ku, Tokyo, Japan
TEL
03-3814-6262
Homepage URL
demand@n-place.co.jp
Sponsor or person
Institute
DEMAND Investigators
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 29 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 01 | Day |
Last modified on
| 2018 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004634
