UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052966 |
|---|---|
| Receipt number | R000060321 |
| Scientific Title | UNLOADERS-PVAD (Unloading and Heart Recovery with Advanced Mechanical Circulatory Support: Optimal Management of Percutaneous Ventricular Assist Device) |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2025/06/23 20:35:31 |
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Basic information
Public title
UNLOADERS-PVAD (Unloading and Heart Recovery with Advanced Mechanical Circulatory Support: Optimal Management of Percutaneous Ventricular Assist Device)
Acronym
UNLOADERS-PVAD
Scientific Title
UNLOADERS-PVAD (Unloading and Heart Recovery with Advanced Mechanical Circulatory Support: Optimal Management of Percutaneous Ventricular Assist Device)
Scientific Title:Acronym
UNLOADERS-PVAD
Region
| Japan |
Condition
Condition
Acute heart failure
Classification by specialty
| Cardiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate characteristics, hemodynamic parameters, adverse events, and outcomes in patients with percutaneous microaxial flow pump device.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death, Reintroduction of mechanical circulatory support
Key secondary outcomes
Complication (Hemolysis, Bleeding, Limb ischemia, Other), Neurologic prognosis
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
Patients who were diagnosed as refractory heart failure including cardiogenic shock and introduced with percutaneous microaxial flow pump.
Key exclusion criteria
Patients who did not consent to participate in the present study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ikeda |
| Middle name | |
| Last name | Yuki |
Organization
Kitasato University School of Medicine
Division name
Cardiovascular Medicine
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa, Japan.
TEL
042-778-8111
y_ikeda@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Ikeda |
| Middle name | |
| Last name | Yuki |
Organization
Kitasato University School of Medicine
Division name
Cardiovascular Medicine
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa, Japan.
TEL
042-778-8111
Homepage URL
y_ikeda@med.kitasato-u.ac.jp
Sponsor or person
Institute
UNLOADERS
Institute
Department
Personal name
Funding Source
Organization
None
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
Kitasato University Medical Ethics Organization
Address
1-15-1 Kitasato, Minami-Ku, Sagamihara, Kanagawa, Japan.
Tel
042-778-8111
rinrib@med.kitasato-u.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
国立循環器病研究センター (大阪府)、日本医科大学 (東京都)、済生会熊本病院 (熊本県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1161/JAHA.125.042249
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1161/JAHA.125.042249
Number of participants that the trial has enrolled
501
Results
Phase-specific hemodynamic criteria are often unmet and are associated with significantly higher risks of short-term fatal events.
Results date posted
| 2025 | Year | 06 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median patient age was 70 years, 73% were male, 61% had myocardial infarction as the underlying cause, 55% were classified as SCA-SWG stage >=D, and 59% received concomitant VA-ECMO support. The Impella CP accounted for 81% of the PVAD devices used.
Participant flow
The achievement rates of hemodynamic management targets during PVAD support, based on previously reported criteria, were 37% at 24 hours after PVAD initiation, 52% at the time of VA-ECMO weaning, and 45% at the time of PVAD weaning.
Adverse events
None
Outcome measures
Hemodynamic indices (pulmonary catheter parameters)
Mortality
Mechanical circulatory support reintroduction
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 10 | Day |
Date analysis concluded
| 2027 | Year | 01 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060321
