NCT06842784

Brief Summary

Extreme heat causes a disproportionate number of hospitalizations and deaths in older adults relative to any other age group. Importantly, many hospitalizations and deaths are primarily due to cardiovascular events such as myocardial infarction. Previous data indicate that older adults have attenuated skin blood flow and sweating responses when exposed to heat, resulting greater increase in core body temperature. Despite these observations, relatively little is known about the risk for myocardial ischemia potentially contributing to the aforementioned higher morbidity and mortality in older adults during heat waves. The broad objective of this work is to determine the impact of ambient heat exposure on myocardial blood flow and flow reserve in young and older adults. Aim 1 will test the hypothesis that older adults exhibit attenuated myocardial flow reserve compared to young adults during heat stress. Aim 2 will determine if the percent of maximal myocardial flow reserve (assess via vasodilator stress) during heat exposure is higher in older adults compared to young adults. The expected outcome from this body of work will improve our understanding of the consequences of aging on cardiovascular responses to ambient heat stress.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
9mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Feb 2025Feb 2027

Study Start

First participant enrolled

February 3, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

February 18, 2025

Last Update Submit

February 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Myocardial flow reserve

    Measured via myocardial contrast echocardiography.

    The difference in the change from baseline to a vasodilator stress test and the change from baseline to after 3-hours of heat stress.

  • Myocardial blood flow

    Measured via myocardial contrast echocardiography.

    The change from baseline to after 3 hours of heat stress.

Secondary Outcomes (4)

  • Core temperature

    The change from baseline to after 3 hours of heat stress..

  • Indices of left and right ventricular function

    At baseline and after 3 hours of heat stress.

  • Heart rate

    At baseline, during exercise- after 20 minutes and 2 hours in the heat, and at rest after 3 hours of heat stress.

  • Blood pressure

    At baseline, during exercise- after 20 minutes and 2 hours in the heat, and at rest after 3 hours of heat stress.

Study Arms (2)

Young participants

Individuals aged 18-39 years

Other: Ambient heat stress

Older participants

Individuals aged 65 years or older

Other: Ambient heat stress

Interventions

3-hour ambient heating in 44°C and 20% relative humidity

Older participantsYoung participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be healthy younger and older individuals identified from the general population.

You may qualify if:

  • Healthy male and female individuals
  • years or 65+ years of age
  • Free of any underlying moderate to serious medical conditions

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Health Presbyterian Hospital Dallas

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

Heat Stress DisordersHyperthermia

Condition Hierarchy (Ancestors)

Wounds and InjuriesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 24, 2025

Study Start

February 3, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations