UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048634 |
|---|---|
| Receipt number | R000055418 |
| Scientific Title | Relationship between Invasive Hemodynamics and Organ Congestion in Acute Heart Failure |
| Date of disclosure of the study information | 2022/08/09 |
| Last modified on | 2024/01/10 13:25:56 |
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Basic information
Public title
Relationship between Invasive Hemodynamics and Organ Congestion in Acute Heart Failure
Acronym
Invasive Hemodynamics and Organ Congestion in AHF
Scientific Title
Relationship between Invasive Hemodynamics and Organ Congestion in Acute Heart Failure
Scientific Title:Acronym
Invasive Hemodynamics and Organ Congestion in AHF
Region
| Japan |
Condition
Condition
Acute Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the relationship between the severity of organ congestion and invasive hemodynamics indices by lung and abdominal echocardiography and CT, and to improve the quality of diagnosis of acute heart failure.
Basic objectives2
Others
Basic objectives -Others
Furthermore, this study aims to clarify the relationship between severity of organ congestion and exercise capacity, quality of life, and prognosis, and to achieve accurate risk stratification in patients with acute heart failure.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To invastigate the relationship between the severity of organ congestion by pulmonary and abdominal echocardiography or CT and invasive hemodynamics in patients with acute heart failure.
Key secondary outcomes
To invastigate the relationship between organ congestion and exercise intolerance and 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects gave written informed
consent to participate in the study.
Key exclusion criteria
Subjects with organic lung diseases such as interstitial pneumonia. Other subjects deemed inappropriate as research subjects by the investigator.
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Kazuonri |
| Middle name | |
| Last name | Omote |
Organization
Hokkaido University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita 15 nishi 7 kitaku Sapporo
TEL
0117066973
omote@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuonri |
| Middle name | |
| Last name | Omote |
Organization
Hokkaido University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita 15 nishi 7 kitaku Sapporo
TEL
0117066973
Homepage URL
omote@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University 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
Secretariat of the Ethics Review Committee for Life and Medical Sciences Research, Clinical Research Supervision Center, Hokkaido University Hospital
Address
Kita 15 nishi 7 kitaku Sapporo
Tel
011-706-7636
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
| 2022 | Year | 08 | Month | 09 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 08 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055418
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
