IEEM-Heat and Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Control Trial, Water-saturated T-shirt trial, Skin-Wetting Trial.
- Who it may be relevant to
- Registry conditions: Heart Failure, Hyperthermia. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Control Trial
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. - Other Water-saturated T-shirt trial
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. - Other Skin-Wetting Trial
All participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will also be sprayed with water periodically.
Primary outcome measures
- 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.)]
- Change in Core Body Temperature in Skin-Wetting Trial [Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)]
- Change in Core Body Temperature in Control Trial [Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)]
- 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.)]
- Change in Skin Temperature in Skin-Wetting Trial [Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)]
- Change in Skin Temperature in Control Trial [Time frame: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)]
Secondary outcome measures (9)
- 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.)]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dal — Dallas
Identifiers
NCT: NCT06961929 · STU20250699