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临床试验/NCT06582680
NCT06582680招募中4 期

Aging, Beta Blockers, and Thermoregulatory Responses

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年10月4日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
入组人数
22
试验地点
2
主要终点
Internal temperature

研究概览

简要总结

We 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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

盲法说明

Neither the participants nor the researchers will know whether the participant received the placebo or one of the beta blocking drugs. Masking will be performed by the research nurse who will know which drug the participant received.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Internal temperature

时间窗: Continuously throughout the 3-hour heat exposure.

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

Whole body sweat rate

时间窗: 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.

次要结局

  • Heart rate(Continuously throughout the 3-hour heat exposure.)
  • Arterial blood pressure(Continuously throughout the 3-hour heat exposure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig Crandall

Professor of Internal Medicine

University of Texas Southwestern Medical Center

研究点 (2)

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