UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021657 |
|---|---|
| Receipt number | 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 | 2024/04/03 16:16:50 |
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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
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
hwada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National hospital organization, Kyoto medical center
Institute
Department
Personal name
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
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
https://doi.org/10.1002/ehf2.13555
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1002/ehf2.13555
Number of participants that the trial has enrolled
1065
Results
A low sVEGFR-2 value was independently associated with cardiovascular death and all-cause death in patients with chronic HF. These associations were pronounced in those with high NT-proBNP levels.
Results date posted
| 2022 | Year | 04 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 08 | Month | 13 | Day |
Baseline Characteristics
patients with HF, who were admitted to hospitals due to acute decompensated HF and were stabilized after initial management.
Participant flow
Blood sample were collected at the time of nearest discharge. Patients were followed up over 2 years.
Adverse events
none
Outcome measures
The outcomes were cardiovascular death, all-cause death, major adverse cardiovascular events (MACE) defined as a composite of cardiovascular death and HF hospitalization, and HF hospitalization.
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
| 2023 | Year | 04 | Month | 30 | Day |
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
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024970
