UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Life Style Support in Patients at High Risk for Heart Failure: Multicenter Randomized Control Study
Title of the study (Brief title)	ELISS-HF
Region	Japan

Condition
Condition	Congestive Heart Failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate feasibility of long-term life style modification support for improving cardiovascular events and death in parients with heart failure or at high risk of heart failure
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Unplanned admission, Cardiovascular events, All cause death, Cardiovascular death, Medical cost, Health care, Walking, Exercise
Key secondary outcomes	QOL, satisfaction, life style, heart failure, self control

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention
Interventions/Control_2	Cotrol
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Born after April 1, 2013 2.History of heart failure admission (>=6months; Framingham criteria), 3.Patients at high risk for heart failue (Coronary artery disease; dilated cardiomyopathy, atrial fibrillation, Uncontrolled hypertension more than 140/90mmHg, Hypertensive ventricular hypertrophy documented by ECG, STT abnormalities in ECG)
Key exclusion criteria	Aortic valve stenosis (>= moderate), Serum Cr (>= 1.5 mg/dl), Severe lumbago and /or knee pain, NYHA class more than 3, Unsuitable cases judged by physician
Target sample size	160

Research contact person
Name of lead principal investigator	Akira Okayama
Organization	National Cardiovascular Center
Division name	Division of preventive medicine
Address	5-7-1 Fujishirodai, Suita, Osaka
TEL	06-6833-5012
Email	aokayama@jrisp.com

Public contact
Name of contact person	Yu Murase
Organization	Research Institute of Strategy for Prevention
Division name	The secretariat
Address	3-6-2 Misaki, Chiyoda-ku, Tokyou
TEL	03-4560-1955
Homepage URL
Email	jimukyoku.murase@jrisp.com

Sponsor
Institute	Research Institute of Strategy for Prevention
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	1. Iwate Medical University, Division of Cardioangiology 2. Tohoku University, Department of Cardiology 3. Fukushima Medical university, Department of Cardiology 4.University of Human Arts and Sciences Department of Health and Nutrition 5. Kyoto University, EBM center 6. Iwate University
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	国立循環器病研究センター(大阪府) 岩手医科大学附属病院(岩手県) 岩手県立二戸病院(岩手県)岩手県立久慈病院(岩手県) 岩手県立釜石病院(岩手県) 岩手県立大船渡病院(岩手県) 岩手県立宮古病院(岩手県) 東北大学病院(宮城県) 福島県立医科大学附属病院(福島県)

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 01 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry	2016 Year 10 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

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

Management information
Registered date	2014 Year 09 Month 03 Day
Last modified on	2017 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017101