Heart FailureNCT06961929
IEEM-Heat and Heart Failure
A study testing Water-saturated T-shirt trial and Skin-Wetting Trial in people with Heart Failure and Hyperthermia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Hyperthermia
- What is being tested?
- Water-saturated T-shirt trial and Skin-Wetting Trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
- -Patients who do not have confirmed diagnosis of NYHA 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 ECG 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
Erin M Harper, B.S., 214-345-4737, erinharper@texashealth.org
Craig G Crandall, PhD, 214-345-4623, craigcrandall@texashealth.org
About this study
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
- Being tested
- Control Trial, Water-saturated T-shirt trial, Skin-Wetting Trial
- Keywords
- heat wave, cardiovascular, cooling strategies, myocardial perfusion
- Medical subject headings
- Heart Failure, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control TrialOther
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 trialOther
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 TrialOther
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 group | Role | What they receive |
|---|---|---|
| Individuals with Congestive Heart Failure (CHF) | Active comparator | Not described Receives: Other: Control Trial; Other: Water-saturated T-shirt trial; Other: Skin-Wetting Trial |
| Individuals without Congestive Heart Failure (Control) | Active comparator | Not described Receives: Other: Control Trial; Other: Water-saturated T-shirt trial; Other: Skin-Wetting Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Oct 2025
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Crandall, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961929
- Sponsor's protocol ID
- STU20250699
- Status last verified
- May 2026
- First submitted
- 29 Apr 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IEEM-Heat and Heart Failure
- ClinicalTrials.gov ID
- NCT06961929
- Acronym / sponsor ID
- STU20250699
- Conditions
- Heart Failure, Hyperthermia
- Keywords
- heat wave, cardiovascular, cooling strategies, myocardial perfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- 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.
Key exclusion criteria (2 listed)
- 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.
- -Patients who do not have confirmed diagnosis of NYHA 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 ECG 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control TrialAll participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will not be given an experimental cooling modality. | Other | Individuals with Congestive Heart Failure (CHF), Individuals without Congestive Heart Failure (Control) |
| Water-saturated T-shirt trialAll 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. | Other | Individuals with Congestive Heart Failure (CHF), Individuals without Congestive Heart Failure (Control) |
| Skin-Wetting TrialAll participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will also be sprayed with water periodically. | Other | Individuals with Congestive Heart Failure (CHF), Individuals without Congestive Heart Failure (Control) |
Primary outcome
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.)
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.
Change in Core Body Temperature in Skin-Wetting Trial
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
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.
Change in Core Body Temperature in Control Trial
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
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.
Change in Skin Temperature in while wearing a water-saturated T-shirt
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
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.
Change in Skin Temperature in Skin-Wetting Trial
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
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.
Change in Skin Temperature in Control Trial
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
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.
9 secondary outcomes
Change in Heart Rate while wearing a water-saturated T-shirt
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Change in Heart Rate in Skin-Wetting Trial
Time frame: Prior to and after each simulated heat wave exposure (approximately 210minutes.)
Change in Heart Rate in Control Trial
Time frame: Prior to and after each simulated heat wave exposure (approximately 210minutes.)
Rate Pressure Product while wearing a water-saturated T-shirt
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
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
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
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Change in Cardiac Output in Skin-Wetting Trial
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Cardiac Output in Control Trial
Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-saturated T-shirt trial and Skin-Wetting Trial in people with Heart Failure and Hyperthermia, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Craig Crandall, PhD (214-345-4623, craigcrandall@texashealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.