UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039026
Receipt number R000044412
Scientific Title Epidemiological Multicenter Study for Tailored Treatment in Heart Failure
Date of disclosure of the study information 2020/01/14
Last modified on 2020/03/21 16:10:28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Epidemiological Multicenter Study for Tailored Treatment in Heart Failure

Acronym

ELMSTAT-HF

Scientific Title

Epidemiological Multicenter Study for Tailored Treatment in Heart Failure

Scientific Title:Acronym

ELMSTAT-HF

Region

Japan


Condition

Condition

Heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The aims of this study are to characterize biological pathways related to response/no-response to guideline-recommended pharmacological therapy (e.g., renin-angiotensin-aldosterone blockers, beta-blockers and anticoagulation) for heart failure, and to develop a novel accurate prognostic model by using a systems biology approach (genome and metabolome) and analyzing the data of clinical imaging with artificial intelligence in addition to the conventional prognostic clinical parameters to build a precision medical platform for heart failure patients.

Basic objectives2

Others

Basic objectives -Others

N/A

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

All-cause death
Re-admission due to worsening heart failure
More than 10% additional reduction on Left ventricular ejection fraction

Key secondary outcomes

Implantation of ventricular assist device
Heart transplantation
New-onset atrial fibrillation
Stroke
Systemic embolism
Acute myocardial infarction
Hospitalization due to major bleeding
Ventricular arrhythmia


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

HF arm
1. 20 years of age or older
2. Patients who meet the diagnostic criteria for heart failure in the
current heart failure guidelines (JCS 2017,ESC 2016)
3. Patients who give written informed consent

AF arm
1. 20 years of age or older
2. Left ventricular ejection fraction of 40% or more
3. NYHA functional class 1
4. Patients who give written informed consent

Control
1. Participants in the Tohoku Medical Megabank Project
2. 20 years of age or older at the time of informed consent.

Key exclusion criteria

HF arm
1. Sepsis
2. Acute coronary syndrome
3. Acute myocarditis
4. Patients who received heart transplantation or can be candidate for heart transplantation (i.e., patients with left ventricular assist device for waiting heart transplantation)
5. Scheduled for open heart surgery within a month
6. Patients who are considered as inappropriate candidate for this study by the principal investigator

AF arm
1. Patients with a history of hospitalization for heart failure
2. Acute coronary symdrome
3. Patients who are considered as inappropriate candidate for this study by the principal investigator

Control
1. Diagnosed as atrial fibrillation
2. Diagnosed as heart failure

Target sample size

7000


Research contact person

Name of lead principal investigator

1st name Toshihisa
Middle name
Last name Anzai

Organization

Faculty of Medicine and Graduate School of Medicine, Hokkaido University

Division name

Department of Cardiovascular Medicine

Zip code

060-8638

Address

Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan

TEL

011-706-6973

Email

anzai@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Toshiyuki
Middle name
Last name Nagai

Organization

Faculty of Medicine and Graduate School of Medicine, Hokkaido University

Division name

Department of Cardiovascular Medicine

Zip code

060-8638

Address

Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan

TEL

011-706-6973

Homepage URL


Email

nagai@med.hokudai.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University

Institute

Department

Personal name



Funding Source

Organization

Non profit foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

Iwate Tohoku Medical Megabank Organization, Iwate Medical University
Division of Cardiology, Department of Internal Medicine, Iwate Medical University
Tohoku Medical Megabank Organization, Tohoku University
Department of Diagnostic Imaging, Hokkaido University Graduate School of Medicine
Laboratory of Media Dynamics, Graduate School of Information Science and Technology, Hokkaido University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University Faculty of Medicine and Graduate School of Medicine Independent Clinical Research Review Committee

Address

Kita 15 Nishi 7, Kita-ku, Sapporo, Hokkaido

Tel

011-706-5003

Email

shomu@med.hokudai.ac.jp


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

北海道大学病院(北海道)、
独立行政法人国立病院機構函館病院(北海道)、
市立函館病院(北海道)、
社会福祉法人函館厚生院函館中央病院(北海道)、
日本赤十字社伊達赤十字病院(北海道)、
苫小牧市立病院(北海道)、
独立行政法人国立病院機構北海道医療センター(北海道)、
市立札幌病院(北海道)、
NTT東日本札幌病院(北海道)、
社会医療法人孝仁会(北海道)、
北海道大野記念病院(北海道)、
社会医療法人社団カレスサッポロ北光記念病院(北海道)、
社会福祉法人北海道社会事業協会小樽病院(北海道)、
独立行政法人労働者健康安全機構北海道中央労災病院(北海道)、
独立行政法人労働者健康安全機構北海道せき損センター(北海道)、
砂川市立病院(北海道)、
日本赤十字社北見赤十字病院(北海道)、
市立釧路総合病院(北海道)、
社会福祉法人北海道社会事業協会帯広病院(北海道)、
医療法人大地小笠原記念札幌病院(北海道)、
医療法人渓和会江別病院(北海道)、
社会医療法人社団カレスサッポロ時計台記念病院(北海道)、
国家公務員共済組合連合会斗南病院(北海道)、
東京医科大学病院(東京都)、
群馬大学医学部付属病院(群馬県)、
岩手医科大学いわて東北メディカル・メガバンク機構 生体情報解析部門(岩手県)
岩手医科大学内科学講座循環器内科分野(岩手県)
東北大学東北メディカル・メガバンク機構 基盤解析事業部(宮城県)
東北大学東北メディカル・メガバンク機構 ゲノム解析部門(宮城県)
北海道大学大学院医学研究院画像診断学教室(北海道)
北海道大学 大学院 情報科学研究科 メディアダイナミクス研究室(北海道)


Other administrative information

Date of disclosure of the study information

2020 Year 01 Month 14 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

Open public recruiting

Date of protocol fixation

2019 Year 12 Month 10 Day

Date of IRB

2019 Year 12 Month 24 Day

Anticipated trial start date

2020 Year 01 Month 14 Day

Last follow-up date

2034 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2019 Year 12 Month 27 Day

Last modified on

2020 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044412


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name