IEEM-Heat and Heart Failure
Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Apr 29, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The clinical trial titled "IEEM-Heat and Heart Failure" is studying how different cooling methods can help people with heart failure during extremely hot weather. The main focus is on whether making the skin wet can help lower body temperature and reduce stress on the heart in these conditions. The trial will compare three different ways of cooling: no cooling, skin wetting, and using a fan alone. Participants will be exposed to simulated heat wave conditions while researchers measure their body temperatures and heart health.
To be eligible, participants with heart failure must be diagnosed with moderate to severe heart failure, while healthy control participants should be free of significant medical issues. Most participants will likely be 45 years old or older. Those with certain medical conditions, high body weight, or smoking history may not be able to join. If you participate, you can expect to undergo tests that will help researchers understand how your body responds to heat and cooling methods during the trial. This research is important as it may lead to better ways to protect individuals with heart failure during hot weather.
Gender
ALL
Eligibility 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 18+ years. However, since they will be age-matched to individuals with CHF, we anticipate most of the participants will be 45+ years old.
- 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. Participants with a body mass index ≥ 35 kg/m2 will be excluded. Current smokers, as well as individuals who regularly smoked within the past 9 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 18+ years, though we anticipate that most participants with heart failure will be 45+ years old.
- 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, as well as those with an ejection fraction \>40%. Patients on anticoagulant therapy will also be excluded. Participants with a body mass index ≥ 35 kg/m2 will be excluded. Current smokers, as well as individuals who regularly smoked within the past 9 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.
About University Of Texas Southwestern Medical Center
The University of Texas Southwestern Medical Center is a leading academic medical institution dedicated to advancing healthcare through innovative research, education, and clinical excellence. With a strong emphasis on translational medicine, the center conducts cutting-edge clinical trials aimed at developing novel therapies and improving patient outcomes across a wide range of diseases. Its multidisciplinary approach leverages a collaborative network of renowned faculty, state-of-the-art facilities, and a commitment to ethical research practices, positioning UT Southwestern at the forefront of medical discovery and patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported