UMIN-CTR Clinical Trial

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
Email	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
Email	h-iwano@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044787