Status:
RECRUITING
IEEM-Heat and Heart Failure
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Heart Failure
Hyperthermia
Eligibility:
All Genders
35+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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 35+ 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. Participants with a body mass index ≥ 35 kg/m2 will be excluded. 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 35+ 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, 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 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.
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06961929
Start Date
October 1 2025
End Date
July 1 2030
Last Update
November 24 2025
Active Locations (1)
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1
Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas
Dallas, Texas, United States, 75231