An interventional study of Control Trial and Water-saturated T-shirt trial in Heart Failure and Hyperthermia, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention
We will test the hypothesis that increasing skin wetness, and thus evaporative cooling, will attenuate the increase in core body temperature and accompanying cardiac stress during heat wave conditions in individuals with congestive heart failure. Secondly, we propose that wearing a water-saturated T-shirt will also be beneficial to attenuate the increase in core body temperature and accompanying cardiac stress during heat wave conditions in individuals with congestive heart failure. To accomplish these objectives, individuals with congestive heart failure and otherwise healthy control individuals will be exposed to the simulated heat wave condition (hot and dry) with the following cooling modalities: A) control trial (no limb immersion or skin wetting), B) skin wetting only trial, and C) water-saturated T-shirt trial in a randomized crossover fashion. Thermoregulatory and cardiovascular responses will be evaluated throughout these simulated heat wave exposures.
Primary outcomes variables will be skin and core temperatures, while secondary variables will include measures of cardiovascular stress, myocardial perfusion, heart rate, and echo-based measures of cardiac function.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 88 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria for healthy control participants:
Exclusion Criteria for healthy control participants:
Inclusion Criteria for Participants with CHF:
- The participant must have a diagnosis of congestive heart failure (e.g., heart failure with reduced ), with the severity categorized as (NYHA) class II or III. Participants must be 45+ years.
Exclusion Criteria for Participants with CHF:
-Patients who do not have confirmed diagnosis of class II or III heart failure will be excluded from the clinical group. Potential participants with cancer, diabetes, neurological disease, lung disease, and/or uncontrolled hypertension will be excluded. Potential participants with a left bundle branch block on will be excluded. Patients on anticoagulant therapy will also be excluded. Current smokers, as well as individuals who regularly smoked within the past 12 months, will be excluded. Further exclusions will include severe valvular or congenital heart disease, acute myocarditis, NYHA Class IV heart failure, and/or manifest/provocable ischemic heart disease.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Control Trial · Other: Water-saturated T-shirt trial · Other: Skin-Wetting Trial
Other: Control Trial · Other: Water-saturated T-shirt trial · Other: Skin-Wetting Trial
All participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will not be given an experimental cooling modality.
All participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will also wear a T-shirt that has been saturated with water.
All participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will also be sprayed with water periodically.
Change in Core Body Temperature while wearing a water-saturated T-shirt
Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Change in Core Body Temperature in Skin-Wetting Trial
Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Change in Core Body Temperature in Control Trial
Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Change in Skin Temperature in while wearing a water-saturated T-shirt
Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Change in Skin Temperature in Skin-Wetting Trial
Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Change in Skin Temperature in Control Trial
Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Change in Heart Rate while wearing a water-saturated T-shirt
Heart rate will be measured from ECG electrodes attached to the participant. Heart rate will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in heart rate.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Change in Heart Rate in Skin-Wetting Trial
Heart rate will be measured from ECG electrodes attached to the participant. Heart rate will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in heart rate.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210minutes.)
Change in Heart Rate in Control Trial
Heart rate will be measured from ECG electrodes attached to the participant. Heart rate will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in heart rate.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210minutes.)
Rate Pressure Product while wearing a water-saturated T-shirt
Rate Pressure Product is calculated by multiplying Systolic Blood Pressure and Heart Rate.
Time frame: At the end of each heat wave exposure. Approximately 210minutes after the start of the heat wave simulation.
Rate Pressure Product in Skin-Wetting Trial
Rate Pressure Product is calculated by multiplying Systolic Blood Pressure and Heart Rate.
Time frame: At the end of each heat wave exposure. Approximately 210minutes after the start of the heat wave simulation.
Rate Pressure Product in Control Trial
Rate Pressure Product is calculated by multiplying Systolic Blood Pressure and Heart Rate.
Time frame: At the end of each heat wave exposure. Approximately 210minutes after the start of the heat wave simulation.
Change in Cardiac Output while wearing a water-saturated T-shirt
Cardiac output (how much blood is ejected from the heart) will be measured using echocardiography. Cardiac output will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in cardiac output.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Change in Cardiac Output in Skin-Wetting Trial
Cardiac output (how much blood is ejected from the heart) will be measured using echocardiography. Cardiac output will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in cardiac output.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Cardiac Output in Control Trial
Cardiac output (how much blood is ejected from the heart) will be measured using echocardiography. Cardiac output will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in cardiac output.
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jul 2030, 57 months after the start.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 57 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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