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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037224
Receipt No. R000042365
Scientific Title Prognostic impact of early induction of intra-aortic balloon pump counterpulsation in high-risk patients with acute heart failure
Date of disclosure of the study information 2019/07/30
Last modified on 2019/07/02

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Basic information
Public title Prognostic impact of early induction of intra-aortic balloon pump counterpulsation in high-risk patients with acute heart failure
Acronym Prognostic impact of early induction of IABPin high-risk patients with AHF
Scientific Title Prognostic impact of early induction of intra-aortic balloon pump counterpulsation in high-risk patients with acute heart failure
Scientific Title:Acronym Prognostic impact of early induction of IABPin high-risk patients with AHF
Region
Japan

Condition
Condition Acute heart failure
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the prognostic impact of early induction of intra-aortic balloon pump counterpulsation in high-risk patients with acute heart failure
Basic objectives2 Others
Basic objectives -Others Cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In-hospital cardiovascular death
Key secondary outcomes The length of hospital stay

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Urgently hospitalized patients due to acutely decompensated heart failure with reduced left ventricular ejection fraction (<35%) and systolic blood pressure (<100mmHg) in a single cardiovascular center between July 2013 and November 2017.
Key exclusion criteria 1. Patients who were implanted Intra-aortic balloon pumping counterpulsation due to percutaneous coronary intarvention procedure-related
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Nobuhisa
Middle name
Last name Hagiwara
Organization Tokyo Women's Medical University
Division name Cardiology
Zip code 1628666
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL +81333538111
Email hagiwara.nobuhisa@twmu.ac.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Jujo
Organization Tokyo Women's Medical University
Division name Cardiology
Zip code 1628666
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL +81333538111
Homepage URL
Email juken1123@mac.com

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Women's Medical University Ethics Committee
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo
Tel +81333538111
Email krinri.bm@twmu.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
2019 Year 07 Month 30 Day

Related information
URL releasing protocol http
Publication of results Unpublished

Result
URL related to results and publications http
Number of participants that the trial has enrolled 59
Results
In-hospital mortality, in AHF patients with severely reduced LV systolic function and unstable hemodynamic status on admission, in the Early-IABP group(induction at <3 days after admission) was 5.6%, which was significantly lower than that in the Late-IABP group (31.3%, p = 0.049) and in No-IABP group (32.0%, p = 0.036).
Results date posted
2019 Year 07 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This high-risk population was typically mid-age and 63% of patients was male. In all patients, the average LVEF was 24.7%, and 78% suffered chronic kidney disease.
Participant flow
The current observational cohort study in a single center initially included 404 consecutive AHF patients who were urgently admitted to the intensive care unit (ICU) between 2013 and 2016. However, patients with LVEF >35%, those with systolic blood pressure on admission >100 mmHg, and those who were implanted IABP due to PCI procedure-related were excluded. Ultimately, 59 patients both with LVEF <35% and systolic blood pressure on admission <100 mmHg as an extremely high-risk population were enrolled in this study. We divided the enrolled patients into 3 groups depending on the IABP use: the Early-IABP group that included patients who were implanted IABP within 3 days after the admission, the Late-IABP group that included patients who were implanted IABP after Day 4, and the No-IABP group that included patients who did not receive IABP support during the hospitalization.
Adverse events
The current study did not result in the substantial increase of complications in the IABP groups.
Outcome measures
The primary endpoint was in-hospital cardiovascular(CV) death. CV death included death caused by an acute myocardial infarction, arrhythmias, heart failure, stroke, CV procedures, CV hemorrhages, and other CV causes, and sudden cardiac death. The length of hospital stay was also compared retrospectively among 3 groups as the secondary endpoint. 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
2015 Year 12 Month 10 Day
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2017 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Induction of IABP at an early phase was associated with better in-hospital prognosis (31.3%, p = 0.049) and shorter duration of hospitalization (p = 0.015) in AHF patients with severely reduced LV systolic function and unstable hemodynamic status on admission.

Management information
Registered date
2019 Year 07 Month 01 Day
Last modified on
2019 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042365

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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