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NCT Number: NCT06582680

Aging, Beta Blockers, and Thermoregulatory Responses

This study will test the hypothesis that the drugs propranolol and metoprolol will result in greater increases in core body temperature during 3 hours of extreme heat exposure in older adults.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

Older individuals are more likely to die or become ill during heat waves. During the 1995 Chicago heat wave, there was 35% increase in hospital admissions for individuals older than 65 years of age. Moreover, adults over the age of 65 have a heat-related death rate that is more than double any other age group. Therefore, with an increasing elderly population that is expected to rise by 60% (to 78 million) by 2035, the causes of this excess mortality must be understood to better protect the ageing United States population. It is notable that selective and non-selective beta blocker drugs are commonly prescribed to older individuals with cardiovascular diseases. In younger individuals exposed to a heat stress, beta blocker administration reduced whole-body sweat rate and skin blood flow responses resulting in greater increases in core body temperature. Notably, nothing is known regarding the effects of beta blockers on thermoregulatory responses during heat exposure in older individuals.

This project will evaluate core body temperature responses to selective and non-selective beta blocker drugs during simulated heat wave exposure in older individuals.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy and free of any significant medical problems
  • Normal resting electrocardiogram
  • 65+ years of age
  • Controlled cholesterol of less than 200 mg/dl
  • Controlled blood pressure of less than 140/90 mmHg

Exclusion criteria

  • Known diseases or other chronic conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, uncontrolled hypertension, and uncontrolled hypercholesterolemia
  • Serious abnormalities detected on routine screening
  • Taking prescribed medications or over-the-counter medications that have known influences on either cardiac function or sweating
  • Current smokers, as well as individuals who regularly smoked within the past 3 years
  • body mass index ≥31 kg/m2

Treatment and study plan

Ambient Heat

Other

Subjects will spend 3-hours in a heat chamber at 41°C and 40% humidity.

Primary outcomes

  1. Internal temperature

    Time frame: Continuously throughout the 3-hour heat exposure.

    The change in internal temperature to the 3-hour heat exposure will be measured.

  2. Whole body sweat rate

    Time frame: Nude body mass will be measured before and after the 3-hour heat exposure.

    Whole body sweat rate will be measured via changes in pre/post nude body mass.

Secondary outcomes

  1. Heart rate

    Time frame: Continuously throughout the 3-hour heat exposure.

    Heart rate will be measured via electrocardiogram.

  2. Arterial blood pressure

    Time frame: Continuously throughout the 3-hour heat exposure.

    Systolic and diastolic arterial blood pressures will be measured via a brachial blood pressure cuff.

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney Kirby, RN

CONTACT

[email protected]

214-345-6502

Erin Harper, MS

CONTACT

[email protected]

214-345-4737

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2024
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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