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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003856
Receipt No. 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

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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
Email

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
Email demand@n-place.co.jp

Sponsor
Institute DEMAND Investigators
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004634

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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