IEEM-Heat and Heart Failure

NCT06961929 | Recruiting

• 1 other identifier: STU20250699
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Hyperthermia

Keywords

heat wave; cardiovascular; cooling strategies; myocardial perfusion

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Prior to and after each simulated heat wave exposure (approximately 210 minutes.)

Secondary Outcomes (9)

• Change in Heart Rate while wearing a water-saturated T-shirt

  Prior to and after each simulated heat wave exposure (approximately 210 minutes.)

• Change in Heart Rate in Skin-Wetting Trial

  Prior to and after each simulated heat wave exposure (approximately 210minutes.)

• Change in Heart Rate in Control Trial

  Prior to and after each simulated heat wave exposure (approximately 210minutes.)

• Rate Pressure Product while wearing a water-saturated T-shirt

  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

  At the end of each heat wave exposure. Approximately 210minutes after the start of the heat wave simulation.

Study Arms (2)

Individuals with Congestive Heart Failure (CHF)

ACTIVE COMPARATOR

Other: Control Trial; Other: Water-saturated T-shirt trial; Other: Skin-Wetting Trial

Individuals without Congestive Heart Failure (Control)

ACTIVE COMPARATOR

Other: Control Trial; Other: Water-saturated T-shirt trial; Other: Skin-Wetting Trial

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.

Individuals with Congestive Heart Failure (CHF); Individuals without Congestive Heart Failure (Control)

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.

Individuals with Congestive Heart Failure (CHF); Individuals without Congestive Heart Failure (Control)

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.

Individuals with Congestive Heart Failure (CHF); Individuals without Congestive Heart Failure (Control)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants must be 45+ years.

You may not qualify if:

• Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 12 months, will be excluded. Subjects who cannot be age and gender matched to an individual in the heart failure group will be excluded.
• \- The participant must have a diagnosis of congestive heart failure (e.g., heart failure with reduced ejection fraction), with the severity categorized as New York Heart Association (NYHA) class II or III. Participants must be 45+ years.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Hyperthermia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Central Study Contacts

Craig Crandall, PhD

CONTACT

214-345-4623; craigcrandall@texashealth.org

Erin Harper, BS

CONTACT

214-345-4737; erinharper2@texashealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)