Cooling methods to lower heat stress in heart failure
IEEM-Heat and Heart Failure
This trial will test whether increasing skin wetness or wearing a water-saturated T-shirt can slow the rise in core temperature and reduce heart stress during heat-wave conditions in people with congestive heart failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06961929 on ClinicalTrials.gov |
What this trial studies
Researchers will expose adults with congestive heart failure and age-matched healthy controls to a simulated hot, dry heat-wave environment in a controlled facility. Each participant will complete three randomized crossover sessions: a control session (no cooling), a skin-wetting session, and a water-saturated T-shirt session. Continuous measures of core temperature and cardiovascular responses will be collected during each exposure. Responses across the three cooling approaches will be compared to determine which intervention best limits temperature rise and cardiac strain.
Who should consider this trial
Good fit: Ideal candidates are adults (generally 45 years and older) with a diagnosis of congestive heart failure who are medically stable and able to undergo controlled heat-exposure testing.
Not a fit: Patients who are clinically unstable, have severe uncontrolled comorbidities, recent smoking history, or cannot safely participate in heat-exposure testing are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, these simple cooling methods could reduce core temperature increases and lower cardiac stress during heat waves, potentially decreasing symptoms and heat-related complications for people with heart failure.
How similar studies have performed: Prior studies in healthy volunteers show that evaporative skin wetting and saturated garments can reduce core temperature, but there is limited data applying these approaches specifically to people with congestive heart failure.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for healthy control participants: * 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. Exclusion Criteria for healthy control participants: * 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. Inclusion Criteria for Participants with CHF: \- 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. Exclusion Criteria for Participants with CHF: -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.
Where this trial is running
Dallas, Texas
- Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Craig Crandall, PhD
- Email: craigcrandall@texashealth.org
- Phone: 214-345-4623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.