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

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Control Trial — OTHER
    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.
  • Water-saturated T-shirt trial — OTHER
    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.
  • Skin-Wetting Trial — OTHER
    All 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

Locations (1)

FacilityCityStateZIPSite coordinators
Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital DallasDallasTexas75231
Erin M Harper, B.S.
214-345-4737
Craig G Crandall, PhD
214-345-4623

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