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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04538144
Other study ID # STU_2019_1759
Secondary ID 1R01AG069005-01
Status Active, not recruiting
Phase
First received
Last updated
Start date January 19, 2021
Est. completion date August 31, 2026

Study information

Verified date January 2024
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the cardiovascular responses of the elderly to heat wave conditions


Description:

Heat waves are lethal and cause a disproportionate number of deaths in the elderly relative to any other age group. It is important to note that such deaths are primarily cardiovascular, not hyperthermia itself, in origin. Nevertheless, we know relatively little about the effects of aging on cardiovascular function during actual heat wave-like conditions. The central hypothesis of this work is that the elderly exhibit greater cardiovascular stress during heat wave conditions. Aim 1 will test the hypothesis that recognized impairments in thermoregulatory capacity in the elderly will culminate in heightened cardiovascular stress during prolonged exposure to heat wave conditions. Comprehensive cardiovascular and thermal responses in the elderly, relative to younger adults, will be evaluated during exposure to two prolonged heat wave conditions: hot and humid (replicating the 1995 Chicago heat wave), very hot and dry (replicating the 2018 Los Angeles heat wave). The expected outcome from this body of work will re-shape our understanding of the consequences of aging on cardiovascular function during heat waves


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date August 31, 2026
Est. primary completion date August 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Healthy male and female individuals - 18-35 years or 65+ years of age - Free of any underlying moderate to serious medical conditions Exclusion Criteria: - Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, uncontrolled hypertension, and uncontrolled hypercholesterolemia. - Taking of any medications (such as beta blockers and non-dihydropyridine calcium channel blockers) that have known influences on either cardiac function or sweating responses. - Abnormalities detected on routine screening. - Individuals who participate in a structured aerobic exercise training program at moderate to high intensities. - Current smokers, as well as individuals who regularly smoked within the past 3 years. - Body mass index of greater than 30 kg/m^2 - Pregnant individuals

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Simulated heat wave
Individuals will be exposed to thermoneutral climate conditions and two simulated heat wave conditions.

Locations

Country Name City State
United States Texas Health Presbyterian Hospital Dallas Dallas Texas

Sponsors (3)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center American Heart Association, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Core body temperature Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill. Prior to and throughout each simulated heat wave exposure; an average of 480 minutes.
Primary Measures of left ventricular function Measures of left ventricular function, such as ventricular wall motion and ventricular filling, will be obtained from echocardiography images. Prior to, during, and after each simulated heat wave exposure; approximately 20 min each
Secondary Skin temperature Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin Prior to and throughout each simulated heat wave exposure; an average of 480 minutes.
Secondary Heart rate Heart rate will be measured from ECG electrodes attached to the participant Prior to and throughout each simulated heat wave exposure; an average of 480 minutes.
Secondary Arterial blood pressure Arterial blood pressure will be measured using a standard arm blood pressure cuff Prior to and throughout each simulated heat wave exposure; an average of 480 minutes.
Secondary Cardiac output Cardiac output (how much blood is ejected from the heart) will be measured using echocardiography and nitrous oxide rebreathing approaches. Prior to, during, and after each simulated heat wave exposure; approximately 20 min each
Secondary Cerebral perfusion Cerebral perfusion will be measured by doppler ultrasound of the internal carotid and vertebral arteries Prior to, during, and after each simulated heat wave exposure; approximately 20 min each
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