Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with Congestive Heart Failure (CHF) | Active Comparator |
| |
| Individuals without Congestive Heart Failure (Control) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Trial | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Core Body Temperature while wearing a water-saturated T-shirt | Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature. | Prior to and after each simulated heat wave exposure (approximately 210 minutes.) |
| Change in Core Body Temperature in Skin-Wetting Trial | Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature. | Prior to and after each simulated heat wave exposure (approximately 210 minutes.) |
| Change in Core Body Temperature in Control Trial | Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature. | Prior to and after each simulated heat wave exposure (approximately 210 minutes.) |
| Change in Skin Temperature in while wearing a water-saturated T-shirt | Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature. | Prior to and after each simulated heat wave exposure (approximately 210 minutes.) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate while wearing a water-saturated T-shirt | Heart rate will be measured from ECG electrodes attached to the participant. Heart rate will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in heart rate. | Prior to and after each simulated heat wave exposure (approximately 210 minutes.) |
Not provided
Inclusion Criteria for healthy control participants:
Exclusion Criteria for healthy control participants:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Craig Crandall, PhD | Contact | 214-345-4623 | craigcrandall@texashealth.org | |
| Rachel Cottle, PhD | Contact | 214-345-4737 | rachelcottle@texashealth.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Exercise and Environmental Medicine - Texas Health Presbyterian Hospital Dallas | Recruiting | Dallas | Texas | 75231 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Water-saturated T-shirt trial | Other | 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. |
|
| Skin-Wetting Trial | 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. |
|
| Change in Skin Temperature in Skin-Wetting Trial | Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature. | Prior to and after each simulated heat wave exposure (approximately 210 minutes.) |
| Change in Skin Temperature in Control Trial | Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature. | Prior to and after each simulated heat wave exposure (approximately 210 minutes.) |
| Change in Heart Rate in Skin-Wetting Trial | Heart rate will be measured from ECG electrodes attached to the participant. Heart rate will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in heart rate. | Prior to and after each simulated heat wave exposure (approximately 210minutes.) |
| Change in Heart Rate in Control Trial | Heart rate will be measured from ECG electrodes attached to the participant. Heart rate will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in heart rate. | Prior to and after each simulated heat wave exposure (approximately 210minutes.) |
| Rate Pressure Product while wearing a water-saturated T-shirt | Rate Pressure Product is calculated by multiplying Systolic Blood Pressure and Heart Rate. | 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 | Rate Pressure Product is calculated by multiplying Systolic Blood Pressure and Heart Rate. | At the end of each heat wave exposure. Approximately 210minutes after the start of the heat wave simulation. |
| Rate Pressure Product in Control Trial | Rate Pressure Product is calculated by multiplying Systolic Blood Pressure and Heart Rate. | 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 | Cardiac output (how much blood is ejected from the heart) will be measured using echocardiography. Cardiac output will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in cardiac output. | Prior to and after each simulated heat wave exposure (approximately 210 minutes.) |
| Change in Cardiac Output in Skin-Wetting Trial | Cardiac output (how much blood is ejected from the heart) will be measured using echocardiography. Cardiac output will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in cardiac output. | Prior to and after each simulated heat wave exposure (approximately 210 minutes.) |
| Cardiac Output in Control Trial | Cardiac output (how much blood is ejected from the heart) will be measured using echocardiography. Cardiac output will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those heart rates will reflect the change in cardiac output. | Prior to and after each simulated heat wave exposure (approximately 210 minutes.) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |