UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diastolic Heart Failure Management by Nifedipine (DEMAND)
Title of the study (Brief title)	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	Hiroyuki Tsutsui
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL	011-706-6973
Email

Public contact
Name of contact person
Organization	Nouvelle Place Inc.
Division name	DEMAND office
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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