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临床试验/NCT03484273
NCT03484273已完成不适用

Body Compression in Postural Tachycardia Syndrome (POTS): Effects on Orthostatic Tolerance

University of Calgary1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Orthostatic Heart Rate (HR) Change

研究概览

简要总结

When an individual with Postural Tachycardia Syndrome (POTS) stands up, their heart rate increases significantly (>30BPM) and they may experience symptoms such as lightheadedness, dizziness, shortness of breath, nausea and mental confusion.

One commonly prescribed treatment for POTS is compression garments. Compression garments squeeze veins to help return blood back to the heart, which may decrease heart rate and symptoms on standing. However, there is little research about the effectiveness of compression in adults with POTS.

In this study, the investigators will use the Lifewrap garment, which compresses the abdomen, pelvis and lower extremities, to evaluate the effectiveness of compression in POTS. The investigators will use a head up tilt (HUT) which will simulate standing. The study participant will participate in 4x 10 minute HUTs wearing 4 different compression configurations:

  1. full abdomen and lower extremity compression
  2. abdominal only compression
  3. leg only compression
  4. No compression

The investigators hypothesize that with full compression, the participant's heart rate increase from lying down to upright will be lower than when they are not wearing any compression. The investigators will also ask the participant about their symptoms when they are upright.

The results of this study could demonstrate the potential benefits of compression and what configuration is most effective. These findings could rapidly translate to the clinical setting, providing improved care.

详细描述

Postural Tachycardia Syndrome (POTS) is a chronic form of orthostatic intolerance marked by a significant and sustained increase in heart rate (HR) upon positional change from supine to standing (>30 beats/min [bpm]) in the absence of orthostatic hypotension (<20/10 mmHg decrease). Symptoms must be present for >6 months and other causes of orthostatic tachycardia must be ruled out. Individuals with POTS report orthostatic symptoms including palpitations, lightheadedness, and mental clouding, which improve on recumbence. The vast majority of individuals diagnosed with POTS are women age 13-50 years.

Upon standing, approximately 500 mL of blood immediately redistributes from the thorax down to the abdomen, buttocks and legs. This leads to sympathetic activation as the baroreceptors sense less pressure. In a healthy individual, HR initially increases 10-20 bpm, and the systolic blood pressure (BP) decreases by approximately 5 mmHg. However, in an individual with POTS, this compensatory mechanism is impaired and HR will increase by >30 bpm and remain at this elevated rate for the duration of standing. In some individuals with POTS, upon standing cerebral blood flow velocity decreases. In other individuals, oscillation of cerebral blood flow due to failure of cerebral autoregulatory mechanisms is observed.

Current treatment of POTS involves pharmacological and non-pharmacological intervention including salt and fluid loading, exercise, and physical countermanuevers. There are no approved medications for use in POTS and all use is off label. Compression garments are also often prescribed. Abdominal/lower extremity compression garments provide pressure to the blood vessels in the legs, thighs and abdomen which can minimize blood pooling and lead to improved blood return to the heart. One such garment is the Lifewrap Non-pneumatic AntiShock garment (NASG), indicated in post-partum hypovolemia.

A pediatric study (n=20) found that orthostatic tachycardia and symptoms were decreased during head up tilt (HUT), with the use of a different NASG compression garment vs. no compression. However, there is no data to validate the efficacy of compression in adults POTS, and also no data to determine which type of compression is most beneficial (e.g. lower leg only, abdomen only, combination).

The investigators hypothesize that the use of the Lifewrap NASG compression garment in a fully applied configuration will decrease orthostatic tachycardia and orthostatic symptoms during a 10 minute HUT vs. no compression garment. The investigators will complete a 4-way randomized crossover study of HUTs with compression applied by the LifeWrap NSAG in at attempt to demonstrate decreased orthostatic tachycardia and increased orthostatic tolerance in individuals with POTS. If successful, this study could provide needed evidence that compression in POTS is a successful non-pharmacological treatment modality, and as well, what type of compression is the most beneficial to patients with this syndrome. These findings could rapidly translate to the clinical setting and improve patient care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Physician diagnosis of Postural Tachycardia Syndrome (POTS)
  • Age 18-60 years (we are an adult group and we do not see pediatric patients clinically and do not have appropriate pediatric expertise)
  • Male and Female
  • Able and willing to provide informed consent
  • Ability to travel to Libin Cardiovascular Institute of Alberta Autonomic Testing Lab at the University of Calgary, Calgary, AB.

排除标准

  • Overt cause for postural tachycardia, i.e., acute dehydration
  • Participants with somatization or severe anxiety symptoms will be excluded (as they may not tolerated study procedures)
  • Pregnant women
  • Inability to tolerate compression garment for the duration of the study
  • Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies

结局指标

主要结局

Orthostatic Heart Rate (HR) Change

时间窗: Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR

The primary outcome measure will be the magnitude of HR change from supine to HUT (max HR between 5-10 min of HUT) for each study arm.

次要结局

  • Change in Systemic Vascular Resistance (SVR)(During the baseline before the HUT and the SVRcorrelating with the maximum HR during 5-10 min HUT, recorded at 1min intervals.)
  • Maximum Upright Heart Rate(During minutes 5-10 of the HUT)
  • Change in Cardiac Output (CO)(During the baseline before the HUT and the CO correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.)
  • Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating(After t=10 of the 10min HUT (or sooner if HUT has to be terminated early due to symptoms))
  • Change in Systolic Blood Pressure (SBP)(During the baseline before the HUT and the SBP correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.)
  • Changes in Stroke Volume(During the baseline before the HUT and the SV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.)
  • Change in Cerebral Blood Flow Velocity (CBFV)(During the baseline before the HUT and the CBFV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.)

研究者

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

Dr. Satish Raj

Professor; Medical Director, Calgary Autonomic Investigation & Management Clinic

University of Calgary

研究点 (1)

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