UMIN-CTR Clinical Trial

Public title

Observational Study Using the Sweat Measurement Device 'GI-1' in Heart Failure Patients

Acronym

GI-1 Sweat Study in HF Patients

Scientific Title

Evaluation of the Sweat Measurement Device 'GI-1' in Heart Failure Patients: An Observational Study

Scientific Title:Acronym

GI-1 Exercise Tolerance in HF

Region

Japan

Condition

Heart failure, myocardial infarction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the utility of the non-invasive sweat measurement device 'GI-1' in assessing exercise tolerance in heart failure patients, whose prevalence is increasing due to aging.

Basic objectives2

Others

Basic objectives -Others

Clinical utility of the device

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II,III

Primary outcomes

1) Correlation Analysis Between Sweat Lactate Threshold (sLT) and Ventilatory Threshold (VT)
The correlation between sLT and VT will be assessed using Pearson correlation coefficient.
A target correlation coefficient of 0.6 or higher is set.
The 95 percent confidence interval (CI) and P-value will be calculated.
The study will be considered successful if a statistically significant correlation is confirmed.
2) Bland-Altman Analysis
The agreement between sLT and VT in terms of workload will be evaluated using Bland-Altman analysis.
A standard deviation within plus or minus 15 watts will be considered clinically acceptable.
3)Inter-Rater Reliability (ICC Analysis)
The determination of sLT and clinical ventilatory threshold (VTcp) will be conducted by three independent raters.
The intraclass correlation coefficient (ICC) will be calculated for each rater.
An ICC greater than 0.7 will be considered indicative of high inter-rater reliability.

Key secondary outcomes

Correlation analysis between the 6-minute walk distance (6MWD) and the sweat lactate threshold (sLT).
Safety assessment: Recording the frequency of erythema, inflammation, and allergic reactions at the device attachment site.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients aged 20 years or older at the time of obtaining informed consent (regardless of gender).
2) Patients who are at least 20 years old at the time of undergoing cardiopulmonary exercise testing (CPX).
3) Patients diagnosed with heart failure or myocardial infarction and undergoing CPX, fulfilling at least one of the following criteria:
Patients with a history of hospitalization for acute decompensated heart failure (ADHF) who meet the following criteria:
In sinus rhythm on admission ECG: NT-proBNP > 200 pg/mL or BNP > 100 pg/mL
In atrial fibrillation on admission ECG: NT-proBNP > 600 pg/mL or BNP > 120 pg/mL
Patients who have experienced heart failure symptoms at least once and are currently receiving diuretic therapy for heart failure.
4) Patients who have received a full explanation of this study, fully understood the details, and voluntarily provided written informed consent to participate.

Key exclusion criteria

1) Patients with severe dermatological disorders.
2) Patients with lacerations at the device attachment site.
3) Patients with significantly reduced sweating, as confirmed by medical history.

Target sample size

50

Name of lead principal investigator

1st name	Taiji
Middle name
Last name	Okada

Organization

Shimane University Faculty of Medicine

Division name

Department of Cardiology

Zip code

693-8501

Address

89-1 Enya-cho, Izumo, Shimane

TEL

+81-853-20-2249

Email

t.dakao@gmail.com

Name of contact person

1st name	Taiji
Middle name
Last name	Okada

Organization

Shimane University Faculty of Medicine

Division name

Department of Cardiology

Zip code

693-8501

Address

89-1 Enya-cho, Izumo, Shimane

TEL

+81-853-20-2249

Homepage URL

Email

t.dakao@gmail.com

Institute

Shimane University

Institute

Department

Personal name

Taiji Okada

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shimane University Hospital, Clinical Trial Review Board

Address

89-1 Enya-cho, Izumo-shi, Shimane, 693-8501 Japan

Tel

0853-20-2515

Email

kenkyu@med.shimane-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

04

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

30

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2025

Year

04

Month

15

Day

Date of IRB

2025

Year

04

Month

23

Day

Anticipated trial start date

2025

Year

05

Month

07

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Methods and Timing of Observation and Testing (ASCII-only version)
Eligible participants who have provided informed consent will be evaluated using the GI-1 sweat lactate device once during cardiopulmonary exercise testing (CPX) and once during a 6-minute walk test.

1. Pre-test assessment items
Basic information: Age (on the day of device use), sex, diagnosis, NYHA class, underlying disease, comorbidities, medical history, current medications, ECG findings

Clinical data:

Blood tests (e.g., WBC, RBC, Hb, Ht, Plt, TP, ALB, T-bil, AST, ALT, LDH, gamma-GTP, Cr, BUN, eGFR, UA, Na, K, Cl, Ca, Mg, P, CRP, Fe, ferritin, TIBC, BNP, FBS, HbA1c, TC, LDL-C, HDL-C, TG, TSH, FT4, FT3, D-dimer, Fib, PT, APTT, AT III)

Body composition (weight, skeletal muscle mass, skeletal muscle index, extracellular water ratio) using InBody

Vital signs: Blood pressure, heart rate, respiratory rate, oxygen saturation (SpO2), body temperature

Echocardiography (data obtained from routine clinical examinations)

2. CPX assessment items
Parameters measured during CPX:

Oxygen uptake (VO2max, percent VO2max)

Ventilatory efficiency (VE/VCO2 slope)

Ventilatory threshold (VT1, AT)

Heart rate (peak HR, percent HRmax)

Heart rate recovery at 1 minute (HRR1min)

Blood pressure (SBP, DBP)

SBP to VO2 slope

Minute ventilation (VE), respiratory rate (RR), maximum voluntary ventilation (MVV), dead space to tidal volume ratio (VD/VT)

Exercise time, peak workload (watts, METs), change in VO2 per workload (delta VO2 per delta W)

Arterial oxygen saturation (SpO2)

Oxygen pulse (O2 pulse)

Ventilatory equivalents (VE/VO2, VE/VCO2)

Device-based measurement: sLT (sweat lactate threshold)

Subjective rating: Borg scale

Registered date

2025

Year

04

Month

16

Day

Last modified on

2026

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065262