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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021657
Receipt No. R000024970
Scientific Title Development of Novel Biomarkers to Predict REHOSPitalization in Chronic Heart Failure
Date of disclosure of the study information 2016/04/01
Last modified on 2019/09/30

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Basic information
Public title Development of Novel Biomarkers to Predict REHOSPitalization in Chronic Heart Failure
Acronym PREHOSP-CHF Study
Scientific Title Development of Novel Biomarkers to Predict REHOSPitalization in Chronic Heart Failure
Scientific Title:Acronym PREHOSP-CHF Study
Region
Japan

Condition
Condition Chronic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the relationship between sVEGFR-2 (and other biomarkers) and clinical outcomes (cardiovascular death and re-hospitalization for heart failure) in patients with chronic heart failure and to establish the novel risk stratification method for predicting re-hospitalization for heart failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cardiovascular death and re-hospitalization for heart failure
Key secondary outcomes All-cause death
Major adverse cardiovascular events
Cardiovascular death
Re-hospitalization for heart failure
All-cause re-hospitalization

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 Patients admitted for acute heart failure who discharge alive from hospital
Key exclusion criteria 1. Patients with acute coronary syndrome within 14 days
2. Patients who plan to undergo elective revascularization, cardiac surgery, or implantable cardiac device therapy after discharge.
3. Malignancy
4. Inflammatory disease
5. Patients with low drug compliance
6. Inability to give written informed consent
7. Under 20 years old
8. Not eligible in the investigator's opinion
Target sample size 1050

Research contact person
Name of lead principal investigator
1st name Moritake
Middle name
Last name Iguchi
Organization National hospital organization, Kyoto medical center
Division name Department of cardiology
Zip code 6128555
Address 1-1, Fukakusamukaihata-cho, Fushimi-ku, Kyoto, Japan 612-8555
TEL 075-641-9161
Email moritake@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Hiromichi
Middle name
Last name Wada
Organization National Hospital Organization Kyoto Medical Center
Division name Division of Translational Disease
Zip code 6128555
Address 1-1, Fukakusamukaihata-cho, Fushimi-ku, Kyoto, Japan 612-8555
TEL 075-641-9161
Homepage URL
Email hwada@kuhp.kyoto-u.ac.jp

Sponsor
Institute National hospital organization, Kyoto medical center
Institute
Department

Funding Source
Organization National hospital organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Hospital Organization
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospiltal Organization central ethics committee
Address 2-5-23 Higashigaoka Meguroku Tokyo Japan
Tel 03-5712-5075
Email 700-kenkyu@mail.hosp.go.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 国立病院機構帯広病院(北海道)
国立病院機構北海道医療センター(北海道)
国立病院機構函館医療センター(北海道)
国立病院機構仙台医療センター(宮城県)
国立病院機構水戸医療センター(茨城県)
国立病院機構栃木医療センター(栃木県)
国立病院機構埼玉病院(埼玉県)
国立病院機構横浜医療センター(神奈川県)
国立病院機構相模原病院(神奈川県)
国立病院機構金沢医療センター(金沢県)
国立病院機構京都医療センター(京都府)
国立病院機構神戸医療センター(兵庫県)
国立病院機構東広島医療センター(広島県)
国立病院機構呉医療センター(広島県)
国立病院機構福山医療センター(広島県)
国立病院機構東徳島医療センター(徳島県)
国立病院機構愛媛医療センター(愛媛県)
国立病院機構九州医療センター(福岡県)
国立病院機構福岡東医療センター(福岡県)
国立病院機構長崎川棚医療センター(長崎県)
国立病院機構長崎病院(長崎県)
国立病院機構熊本医療センター(熊本県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 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 No longer recruiting
Date of protocol fixation
2014 Year 11 Month 25 Day
Date of IRB
2014 Year 12 Month 12 Day
Anticipated trial start date
2014 Year 12 Month 15 Day
Last follow-up date
2022 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To examine the relationship between sVEGFR-2 (or other biomarkers) and cardiovascular events in patients with chronic heart failure, dividing the patients into HFpEF or HFrEF, or according to severity of heart failure or presence of established risk factors.

Management information
Registered date
2016 Year 03 Month 28 Day
Last modified on
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024970

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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