IEEM-Heat and Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2030-07-01

Brief Summary

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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 hand \& forearm cooling (via cool water immersion) will also be benefitial 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) cool water limb immersion 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.

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Detailed Description

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Conditions

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Heart Failure Hyperthermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Individuals with Congestive Heart Failure (CHF)

Group Type ACTIVE_COMPARATOR

Control Trial

Intervention Type OTHER

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.

Cool water limb immersion

Intervention Type OTHER

All participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will also immerse their hands and forearms in cool water.

Skin-Wetting Trial

Intervention Type OTHER

All participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will also be sprayed with water periodically.

Individuals without Congestive Heart Failure (Control)

Group Type ACTIVE_COMPARATOR

Control Trial

Intervention Type OTHER

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.

Cool water limb immersion

Intervention Type OTHER

All participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will also immerse their hands and forearms in cool water.

Skin-Wetting Trial

Intervention Type OTHER

All participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will also be sprayed with water periodically.

Interventions

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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.

Intervention Type OTHER

Cool water limb immersion

All participants will be exposed to a period of hyperthermia (hot and dry). In this condition, participants will also immerse their hands and forearms in cool water.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

\- 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

* 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.

-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.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes