IEEM-Heat and Heart Failure
Part of paid clinical trials in Dallas, Texas.
- Sponsor
- University of Texas Southwestern Medical Center
- Study ID
- NCT06961929
- Status
- Recruiting
Conditions
- Heart Failure
- Hyperthermia
Eligibility Criteria
- Sex
- ALL
- Age
- 45 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Control Trial — OTHERAll participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will not be given an experimental cooling modality.
- Water-saturated T-shirt trial — OTHERAll 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.
- Skin-Wetting Trial — OTHERAll participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will also be sprayed with water periodically.
Study Details
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.
Key Dates
- Start date
- Oct 1, 2025
- Status verified
- May 2026
- Primary completion
- Jul 1, 2030
- Completion
- Jul 1, 2030
Study Design
- Enrollment
- 88 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- PREVENTION
Arms
- Active Comparator: Individuals with Congestive Heart Failure (CHF)
- Active Comparator: Individuals without Congestive Heart Failure (Control)
Primary Outcome Measure
Change in Core Body Temperature while wearing a water-saturated T-shirt [ Time Frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.) ]
Central Contacts
- Craig Crandall, PhD214-345-4623
- Rachel Cottle, PhD214-345-4737
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas | Dallas | Texas | 75231 |
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