Aging Clinical Trial
Official title:
Heat Waves in the Elderly: Reducing Thermal and Cardiovascular Consequences
The purpose of this study is to assess how well cooling modalities work in reducing cardiovascular stress of the elderly to heat wave conditions
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 31, 2026 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - 65 years of age or older - Free of any significant underlying medical problems based upon a detailed medical history and physical exam Exclusion Criteria: - Known heart disease - Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia etc; - Abnormality detected on routine screening suggestive of provokable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram. - Current smokers, as well as individuals who regularly smoked within the past 3 years - Subject with a body mass index =31 kg/m2 - Pregnant individuals |
Country | Name | City | State |
---|---|---|---|
United States | Texas Health Presbyterian Hospital Dallas | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in core body temperature | Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer | Body core temperature will be obtained within 60 min before the heat wave exposure after the 3 hour heat wave exposure. | |
Primary | Change in left ventricular function | Measures of left ventricular function, such as ventricular wall motion and ventricular filling, will be obtained from echocardiography images. | Within 60 minutes before each simulated heat wave exposure, around minute 90 of the heat wave exposure, and at the end of the 3 hour heat wave exposure | |
Secondary | Heart rate | Heart rate will be measured from ECG electrodes attached to the participant | Prior to and throughout each simulated heat wave exposure; approximately 420 minutes | |
Secondary | Cardiac output | Cardiac output (how much blood is ejected from the heart) will be measured using 3D echocardiography. | Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours) | |
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 | Whole body sweat rate | Whole body sweat rate will be measured by through nude weight of the participant. | Within 60 minutes before each simulated heat wave exposure and within 30 minutes after each heat wave exposure. | |
Secondary | Markers of renal function and injury - Cystatin C | Markers of renal function and injury (e.g., cystatin C) will be evaluated from blood sampling collection. | Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure | |
Secondary | Markers of renal function and injury - Creatinine Clearance | Markers of renal function and injury (e.g., creatinine clearance) will be evaluated from blood sampling and urine collection. | Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure | |
Secondary | Markers of renal function and injury - Insulin-like growth factor-binding protein 7 | Markers of renal function and injury (e.g., Insulin-like growth factor-binding protein 7) will be evaluated from urine sampling. | Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure | |
Secondary | Markers of renal function and injury - Tissue inhibitor of metalloproteinases 2 | Markers of renal function and injury (e.g., Tissue inhibitor of metalloproteinases 2) will be evaluated from urine sampling. | Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure | |
Secondary | Cerebral perfusion | Cerebral perfusion will be measured by Doppler ultrasound of the internal carotid and vertebral arteries. | Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours) | |
Secondary | High sensitive cardiac troponin | A plasma-based marker of cardiac stress (high sensitive cardiac troponin) be evaluated from blood sampling. | Within 60 minutes before each simulated heat wave exposure, during each simulated heat wave exposure (up to 3 hours), and within 2 hours after the simulated heat wave exposure | |
Secondary | Skin temperature | Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin | Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours) | |
Secondary | Forced vital capacity (FVC) | Forced vital capacity will be obtained from spirometry | Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours) |
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