UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061600 |
|---|---|
| Receipt number | R000070474 |
| Scientific Title | A retrospective and prospective observational study of patients with severe heart failure or shock admitted to the intensive care unit |
| Date of disclosure of the study information | 2026/05/17 |
| Last modified on | 2026/05/17 07:20:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A retrospective and prospective observational study of patients with severe heart failure or shock admitted to the intensive care unit
Acronym
A retrospective and prospective observational study of patients with severe heart failure or shock admitted to the intensive care unit
Scientific Title
A retrospective and prospective observational study of patients with severe heart failure or shock admitted to the intensive care unit
Scientific Title:Acronym
A retrospective and prospective observational study of patients with severe heart failure or shock admitted to the intensive care unit
Region
| Japan |
Condition
Condition
acute heart failure, cardiogenic shock, sepsis, acute myocardial infarction, fulminant myocarditis, pulmonary embolism, ventricular arrhythmias, cardiac arrest, PCCS and post-cardiac arrest syndrome
Classification by specialty
| Medicine in general | Cardiology | Cardiovascular surgery |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Despite advances in contemporary cardiovascular intensive care, mortality among patients who develop cardiogenic shock due to acute myocardial infarction remains high, with approximately half of affected patients dying. Recently, the use of the Impella mechanical circulatory support device was shown to reduce mortality in patients with cardiogenic shock. In addition, transition from an open ICU model to a semi-closed ICU model has also been associated with improved survival. In parallel, there has been growing interest in optimizing hemodynamic management strategies for critically ill patients with cardiovascular disease and shock. Against this background, we established the present database to support future improvements in the management and outcomes of patients with severe cardiovascular disease and shock.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital death
Key secondary outcomes
bleeding events, ischemic events, hemolysis, acute kidney injury, initiation of renal replacement therapy, amount of blood transfusion, use of pharmacological circulatory support agents, and 30-day mortality
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible patients were those admitted to the intensive care unit with severe heart failure, cardiogenic shock, sepsis, or those who received mechanical circulatory support, and who met the following inclusion and exclusion criteria.
Key exclusion criteria
Age of 100 years or older
Refusal to participate in the study
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kanenawa |
Organization
Kokura memorial hospital
Division name
Cardiology
Zip code
8020001
Address
3-2-1 Asano, Kokura kita-ku,Kitakyushu-city,
TEL
093-511-2000
kanesannsann@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kanenawa |
Organization
Kokura memorial hospital
Division name
Cardiology
Zip code
8020001
Address
Asano3-2-1, Kokurakita-ku, Kitakyusyu-shi
TEL
093-511-2000
Homepage URL
kanesannsann@yahoo.co.jp
Sponsor or person
Institute
Kokura memoria hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Clinical research center,Kokura Memorial Hospital
Address
3-2-1 Asano, Kokura kita-ku,Kitakyushu-city,
Tel
0935112000
crc@kokurakinen.or.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
| 2026 | Year | 05 | Month | 17 | 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
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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective cohort study
Management information
Registered date
| 2026 | Year | 05 | Month | 17 | Day |
Last modified on
| 2026 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070474
