UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048017 |
|---|---|
| Receipt number | R000054205 |
| Scientific Title | Relationship between elevated lactate levels and prognosis in patients with acute heart failure |
| Date of disclosure of the study information | 2022/06/09 |
| Last modified on | 2022/06/09 22:54:46 |
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Basic information
Public title
Relationship between elevated lactate levels and prognosis in patients with acute heart failure
Acronym
Lactate elevation in AHF
Scientific Title
Relationship between elevated lactate levels and prognosis in patients with acute heart failure
Scientific Title:Acronym
Lactate elevation in AHF
Region
| Japan |
Condition
Condition
Acute Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between elevated lactate levels and prognosis in patients with acute heart failure
Basic objectives2
Others
Basic objectives -Others
usefulness of lactate measurement in acute heart failure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between physical and echocardiographic findings of impaired organ perfusion, elevated lactate levels and mortality and heart failure rehospitalization.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 20 years of age or older admitted with a diagnosis of acute heart failure
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Horiuchi |
Organization
Mitsui Memorial Hospital
Division name
Division of cardiology
Zip code
1018643
Address
Izumicho-1, Kanda, Chiyoda-ku, Tokyo
TEL
0338629111
yooouyou@gmail.com
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Horiuchi |
Organization
Mitsui Memorial Hospital
Division name
Division of cardiology
Zip code
1018643
Address
Izumicho-1, Kanda, Chiyoda-ku, Tokyo
TEL
0338629111
Homepage URL
yooouyou@gmail.com
Sponsor or person
Institute
Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
NA
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
Mitsui Memorial Hospital
Address
Izumicho-1, Kanda, Chiyoda-ku, Tokyo
Tel
0338629111
c-uno@mitsuihosp.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
| 2022 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Lactate levels
Physical findings of low perfusion: cold extremities, oliguria, altered neurologic status/delirium, decreased exercise capacity, fatigue
Echocardiographic findings: LVDd, LVDs, LVEF, SVI, LAD, LAV, IVS, PW, E wave, A wave, E/A, E', TAPSE, FAC, TRPG, presence of valvular disease, left ventricular wall motion abnormality
Primary endpoint: composite endpoint of death or heart failure hospitalization within 1 year of admission
Secondary endpoints
Composite endpoint of death during hospitalization, use of circulatory agonists, hemodialysis, and mechanical ventilation
Management information
Registered date
| 2022 | Year | 06 | Month | 09 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054205
