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IEEM-Heat and Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether wetting the skin or wearing a water-soaked T-shirt can limit body heat and heart strain in hot, dry conditions. It is for adults age 45 or older with heart failure, a condition where the heart does not pump well, and healthy adults. Each person will try both cooling methods and no cooling in a randomly chosen order.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All participants must be age 45 or older.
  • Healthy group: Have no major health problems based on a health history and physical exam.
  • Healthy group: Have a normal resting ECG, a test of the heart’s electrical activity.
  • Heart failure group: Have confirmed NYHA class II or III heart failure, meaning symptoms limit physical activity.

Who can't join

  • Both groups: Smoke now or smoked regularly within the past 12 months.
  • Both groups: Have cancer, diabetes, a nervous system disease, lung disease, or high blood pressure that is not controlled.
  • Healthy group: Have known heart disease, another long-term illness needing regular treatment, or serious problems found during screening.
  • Healthy group: Cannot be matched by age and gender to someone in the heart failure group.
  • Heart failure group: Do not have confirmed class II or III heart failure, or have class IV heart failure, with symptoms even at rest.
  • Heart failure group: Have left bundle branch block, an electrical signal problem seen on an ECG, or take blood-thinning drugs that prevent clots.
  • Heart failure group: Have severe heart valve disease, severe heart disease present at birth, or sudden inflammation of the heart muscle.
  • Heart failure group: Have heart disease that reduces blood flow to the heart, either already present or brought on during testing.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX