UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037224 |
|---|---|
| Receipt number | 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 11:26:23 |
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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
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
juken1123@mac.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042365
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