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 | 2024/05/02 09:12:29 |
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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
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
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
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
Partially published
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
| 2024 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044412
