Heart failure, myocardial infarction
Conditions
Interventions
None listed
Sponsors
Shimane University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactTaiji Okada
Shimane University Faculty of Medicine Department of Cardiology
Outcome results
None listed