UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039687 |
|---|---|
| Receipt number | R000044787 |
| Scientific Title | PRospect trial to elucidate the utility of EchocarDIography-based Cardiac ouTput in acute heart failure (PREDICT) study |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2021/06/01 13:53:17 |
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Basic information
Public title
PRospect trial to elucidate the utility of EchocarDIography-based Cardiac ouTput in acute heart failure
(PREDICT) study
Acronym
PREDICT
Scientific Title
PRospect trial to elucidate the utility of EchocarDIography-based Cardiac ouTput in acute heart failure (PREDICT) study
Scientific Title:Acronym
PREDICT
Region
| Japan |
Condition
Condition
Acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the predictive value of echocardiographic LV output for early WHF in comparison with conventional low perfusion findings.
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Worsening heart failure defined as need for initiation of positive inotropic agents within 7 days after the admission
Key secondary outcomes
Worsening renal function defined as an increase in serum creatinine of 0.3 mg/dL during the treatment, time duration for bed rest, inhospital duration, and all cause mortality during the hospital treatment.
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
Adult patients who will admit to the 16 participating hospitals due to worsening heart failure diagnosed based on Framingham criteria from January 2019 to September 2020 will be enrolled.
Key exclusion criteria
Patients with acute coronary syndrome, those need for hemodialysis, and those who had been already received positive inotropic agents before the index echocardiography.
Target sample size
430
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Iwano |
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
TEL
011-706-6973
h-iwano@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Iwano |
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
TEL
011-706-6973
Homepage URL
h-iwano@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in Hokkaido University Hospital
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
Tel
011-716-1161
crjimu@huhp.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
Other administrative information
Date of disclosure of the study information
| 2020 | 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
292
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
| 2018 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 05 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 05 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 05 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Early worsening heart failure (WHF), defined as worsening of symptoms and signs of heart failure requiring intensification of medical or mechanical therapy during an admission for acute decompensated heart failure (ADHF), has recently been recognized as a risk of morbidity or mortality after the discharge. Although echocardiographic parameters of left ventricular (LV) output has been shown to be associated with long-term outcome in heart failure patients, its predictive value for early WHF has not been elucidated.
Management information
Registered date
| 2020 | Year | 03 | Month | 04 | Day |
Last modified on
| 2021 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044787
