UMIN-CTR Clinical Trial

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
Email	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
Email	yooouyou@gmail.com

Sponsor
Institute	Mitsui Memorial Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054205