IEEM-Heat and Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in Core Body Temperature in Skin-Wetting Trial
研究概览
简要总结
We will test the hypothesis that increasing skin wetness, and thus evaporative cooling, will attenuate the increase in core body temperature and accompanying cardiac stress during heat wave conditions in individuals with congestive heart failure. Secondly, we propose that wearing a water-saturated T-shirt will also be beneficial to attenuate the increase in core body temperature and accompanying cardiac stress during heat wave conditions in individuals with congestive heart failure. To accomplish these objectives, individuals with congestive heart failure and otherwise healthy control individuals will be exposed to the simulated heat wave condition (hot and dry) with the following cooling modalities: A) control trial (no limb immersion or skin wetting), B) skin wetting only trial, and C) water-saturated T-shirt trial in a randomized crossover fashion. Thermoregulatory and cardiovascular responses will be evaluated throughout these simulated heat wave exposures.
Primary outcomes variables will be skin and core temperatures, while secondary variables will include measures of cardiovascular stress, myocardial perfusion, heart rate, and echo-based measures of cardiac function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for healthy control participants:
- •Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants must be 45+ years.
排除标准
- •for healthy control participants:
- •Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 12 months, will be excluded. Subjects who cannot be age and gender matched to an individual in the heart failure group will be excluded.
- •Inclusion Criteria for Participants with CHF:
- •- The participant must have a diagnosis of congestive heart failure (e.g., heart failure with reduced ejection fraction), with the severity categorized as New York Heart Association (NYHA) class II or III. Participants must be 45+ years.
- •Exclusion Criteria for Participants with CHF:
- •Patients who do not have confirmed diagnosis of NYHA class II or III heart failure will be excluded from the clinical group. Potential participants with cancer, diabetes, neurological disease, lung disease, and/or uncontrolled hypertension will be excluded. Potential participants with a left bundle branch block on ECG will be excluded. Patients on anticoagulant therapy will also be excluded. Current smokers, as well as individuals who regularly smoked within the past 12 months, will be excluded. Further exclusions will include severe valvular or congenital heart disease, acute myocarditis, NYHA Class IV heart failure, and/or manifest/provocable ischemic heart disease.
研究组 & 干预措施
Individuals with Congestive Heart Failure (CHF)
干预措施: Control Trial (Other)
Individuals with Congestive Heart Failure (CHF)
干预措施: Water-saturated T-shirt trial (Other)
Individuals with Congestive Heart Failure (CHF)
干预措施: Skin-Wetting Trial (Other)
Individuals without Congestive Heart Failure (Control)
干预措施: Control Trial (Other)
Individuals without Congestive Heart Failure (Control)
干预措施: Water-saturated T-shirt trial (Other)
Individuals without Congestive Heart Failure (Control)
干预措施: Skin-Wetting Trial (Other)
结局指标
主要结局
Change in Core Body Temperature in Skin-Wetting Trial
时间窗: Prior to and after each simulated heat wave exposure (approximately 180 minutes.)
Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature.
Change in Core Body Temperature in Control Trial
时间窗: Prior to and after each simulated heat wave exposure (approximately 180 minutes.)
Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature.
Change in Skin Temperature in Skin-Wetting Trial
时间窗: Prior to and after each simulated heat wave exposure (approximately 180 minutes.)
Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature.
Change in Skin Temperature in Control Trial
时间窗: Prior to and after each simulated heat wave exposure (approximately 180 minutes.)
Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature.
Change in Core Body Temperature while wearing a water-saturated T-shirt
时间窗: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature.
Change in Core Body Temperature in Skin-Wetting Trial
时间窗: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature.
Change in Core Body Temperature in Control Trial
时间窗: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Core body temperature will be measured from gastrointestinal temperature via an ingestible telemetric pill or rectal temperature via telemetric pill suppository or rectal thermistor. Core body temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in core body temperature.
Change in Skin Temperature in while wearing a water-saturated T-shirt
时间窗: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature.
Change in Skin Temperature in Skin-Wetting Trial
时间窗: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature.
Change in Skin Temperature in Control Trial
时间窗: Prior to and after each simulated heat wave exposure (approximately 210 minutes.)
Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. Skin temperature will be measured at baseline as well as at the end of the hyperthermia simulation. The difference of those temperatures will reflect the change in skin temperature.
次要结局
- Change in Heart Rate in Skin-Wetting Trial(Prior to and after each simulated heat wave exposure (approximately 180 minutes.))
- Change in Heart Rate in Control Trial(Prior to and after each simulated heat wave exposure (approximately 180 minutes.))
- Rate Pressure Product in Control Trial(At the end of each heat wave exposure. Approximately 180 minutes after the start of the heat wave simulation.)
- Change in Cardiac Output in Skin-Wetting Trial(Prior to and after each simulated heat wave exposure (approximately 180 minutes.))
- Cardiac Output in Control Trial(Prior to and after each simulated heat wave exposure (approximately 180 minutes.))
- Rate Pressure Product in Skin-Wetting Trial(At the end of each heat wave exposure. Approximately 180 minutes after the start of the heat wave simulation.)
- Change in Heart Rate while wearing a water-saturated T-shirt(Prior to and after each simulated heat wave exposure (approximately 210 minutes.))
- Change in Heart Rate in Skin-Wetting Trial(Prior to and after each simulated heat wave exposure (approximately 210minutes.))
- Change in Heart Rate in Control Trial(Prior to and after each simulated heat wave exposure (approximately 210minutes.))
- Rate Pressure Product while wearing a water-saturated T-shirt(At the end of each heat wave exposure. Approximately 210minutes after the start of the heat wave simulation.)
- Rate Pressure Product in Skin-Wetting Trial(At the end of each heat wave exposure. Approximately 210minutes after the start of the heat wave simulation.)
- Rate Pressure Product in Control Trial(At the end of each heat wave exposure. Approximately 210minutes after the start of the heat wave simulation.)
- Change in Cardiac Output while wearing a water-saturated T-shirt(Prior to and after each simulated heat wave exposure (approximately 210 minutes.))
- Change in Cardiac Output in Skin-Wetting Trial(Prior to and after each simulated heat wave exposure (approximately 210 minutes.))
- Cardiac Output in Control Trial(Prior to and after each simulated heat wave exposure (approximately 210 minutes.))
研究者
Craig Crandall
Principal Investigator
University of Texas Southwestern Medical Center