- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04538144
Cardiovascular Responses to Heat Waves in the Elderly
January 29, 2024 updated by: Craig Crandall, University of Texas Southwestern Medical Center
Heat Waves in the Elderly: Reducing Thermal and Cardiovascular Consequences
The purpose of this study is to assess the cardiovascular responses of the elderly to heat wave conditions
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed 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
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bonnie Orth, MS
- Phone Number: 214-345-4737
- Email: BonnieOrth@texashealth.org
Study Contact Backup
- Name: Zachary McKenna, PhD
- Phone Number: 214-345-4623
- Email: zacharymckenna@texashealth.org
Study Locations
-
-
Texas
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Dallas, Texas, United States, 75231
- Texas Health Presbyterian Hospital Dallas
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study population will be healthy younger and older individuals identified from the general population.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Younger participants
Individuals aged 18-39 years
|
Individuals will be exposed to thermoneutral climate conditions and two simulated heat wave conditions.
|
Older participants
Individuals aged 65 years or older
|
Individuals will be exposed to thermoneutral climate conditions and two simulated heat wave conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Core body temperature
Time Frame: Prior to and throughout each simulated heat wave exposure; an average of 480 minutes.
|
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.
|
Measures of left ventricular function
Time Frame: Prior to, during, and after each simulated heat wave exposure; approximately 20 min each
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin temperature
Time Frame: Prior to and throughout each simulated heat wave exposure; an average of 480 minutes.
|
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.
|
Heart rate
Time Frame: Prior to and throughout each simulated heat wave exposure; an average of 480 minutes.
|
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.
|
Arterial blood pressure
Time Frame: Prior to and throughout each simulated heat wave exposure; an average of 480 minutes.
|
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.
|
Cardiac output
Time Frame: Prior to, during, and after each simulated heat wave exposure; approximately 20 min each
|
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
|
Cerebral perfusion
Time Frame: Prior to, during, and after each simulated heat wave exposure; approximately 20 min each
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2021
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
August 28, 2020
First Submitted That Met QC Criteria
September 2, 2020
First Posted (Actual)
September 3, 2020
Study Record Updates
Last Update Posted (Actual)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU_2019_1759
- 1R01AG069005-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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