UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059098 |
|---|---|
| Receipt number | R000067569 |
| Scientific Title | Exploratory study on exercise capacity assessment using a sweat lactate sensor in patients with heart failure and implanted left ventricular assist devices |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/09/16 17:20:08 |
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Basic information
Public title
A study of non-invasive exercise evaluation using a sweat lactate sensor in patients with heart failure and ventricular assist devices
Acronym
SWEAT-HF study
Scientific Title
Exploratory study on exercise capacity assessment using a sweat lactate sensor in patients with heart failure and implanted left ventricular assist devices
Scientific Title:Acronym
SWEAT-HF trial
Region
| Japan |
Condition
Condition
patients with heart failure and ventricular assist devices
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the validity and feasibility of sweat lactate threshold (sLT) measurement using a sweat lactate sensor in patients with heart failure and implanted left ventricular assist devices, in order to explore its utility as a non-invasive method for assessing exercise capacity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement between sweat lactate threshold (sLT) and ventilatory threshold (VT) in patients who underwent cardiopulmonary exercise testing (CPX), assessed by correlation coefficient and Bland-Altman analysis. The evaluation will be performed at baseline (registration).
Key secondary outcomes
Success rate of sweat lactate threshold (sLT) measurement in all subjects, determined by three independent evaluators. Evaluation at baseline (registration).
Association of sLT with exercise heart rate, Borg scale, and walking distance. Evaluation at baseline (registration).
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 hospitalized for heart failure or patients with an implanted left ventricular assist device(LVAD)at our hospital
Age >= 20 years
Patients who have received an explanation of the study objectives and methods and have provided written informed consent
Key exclusion criteria
Patients with skin lesions on the forehead that make sensor attachment difficult
Patients with severe activity limitation who cannot undergo exercise testing or rehabilitation
Patients judged inappropriate for participation by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Isotani |
Organization
Institute of Science Tokyo Hospital
Division name
Department of Cardiology
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
isotani.yoshitaka@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Isotani |
Organization
Institute of Science Tokyo Hospital
Division name
Department of Cardiology
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
isotani.yoshitaka@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo Hospital
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
Institute of Science Tokyo Hospital
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-4547
rinri.adm@tmd.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
| 2025 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted as an exploratory clinical study with the approval of the Ethics Committee of Tokyo Science University Hospital. The sweat lactate sensor (GI-1) used in this study is provided free of charge by Grace Imaging Inc., and the investigators have no financial conflicts of interest. Patient enrollment will begin after ethics committee approval.
Management information
Registered date
| 2025 | Year | 09 | Month | 16 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067569
