UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015043
Receipt number R000017101
Scientific Title Effects of Life Style Support in Patients at High Risk for Heart Failure: Multicenter Randomized Control Study
Date of disclosure of the study information 2014/09/05
Last modified on 2017/03/30 16:31:32

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Basic information

Public title

Effects of Life Style Support in Patients at High Risk for Heart Failure: Multicenter Randomized Control Study

Acronym

ELISS-HF

Scientific Title

Effects of Life Style Support in Patients at High Risk for Heart Failure: Multicenter Randomized Control Study

Scientific Title:Acronym

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

1st name
Middle name
Last name Akira Okayama

Organization

National Cardiovascular Center

Division name

Division of preventive medicine

Zip code


Address

5-7-1 Fujishirodai, Suita, Osaka

TEL

06-6833-5012

Email

aokayama@jrisp.com


Public contact

Name of contact person

1st name
Middle name
Last name Yu Murase

Organization

Research Institute of Strategy for Prevention

Division name

The secretariat

Zip code


Address

3-6-2 Misaki, Chiyoda-ku, Tokyou

TEL

03-4560-1955

Homepage URL


Email

jimukyoku.murase@jrisp.com


Sponsor or person

Institute

Research Institute of Strategy for Prevention

Institute

Department

Personal name



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)



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

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


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

2012 Year 11 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017101


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name