Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome - Screening Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- blood volume deviation (%) from individual predicted volumes
研究概览
简要总结
The purpose of the study is to determine whether patients meet criteria for Postural Tachycardia Syndrome (or not) and have reduced blood volume (or not). Both of these are important screening elements to Aim 3 of a National Institutes of Health Grant. The purposes of Aim 3 are to determine 1. whether a high dietary sodium level appropriately expands plasma volume in Postural Orthostatic Tachycardia, 2. whether plasma renin activity and aldosterone are modified appropriately by changes in dietary sodium in Postural Tachycardia Syndrome and 3. whether patients with Postural Tachycardia Syndrome have improvements in their orthostatic tachycardia and symptoms as a result of a high dietary sodium level.
详细描述
The protocol consists of a screening visit and evaluation of their autonomic nervous system status. The following activities are part of this study. Subjects may stay for 2 nights and 3 study days.
Day 0 Participants will be admitted to the Clinical Research Center, their medical history, physical exam, routine lab work (hemoglobin/hematocrit & CMP) and a serum pregnancy test will be done during that first day. They will also be asked to fill out a health questionnaire. Later that day they will be evaluated to determine the extent of fatigue, depression and anxiety ratings, autonomic symptoms and quality of life, with the use of questionnaires.
Subjects may be asked to stop taking some medications for up to 7 days; it will be decided on an individual basis and after considering each medication and its effect to the autonomic nervous system. If subjects are asked to discontinue the medication, they will ask them to keep a diary of symptoms and to contact the PI or staff by phone if any new symptom appears. If necessary, medications will be restarted.
Testing day 1:
In the morning during the posture test, 5 teaspoons of blood will be drawn while subject is lying down, and after sitting and or standing for 30 minutes to measure substances produced by the body in response to inflammation and oxidative stress and to determine hormones that regulate the blood pressure. Blood pressure and heart rate will be measured in these different positions. A total of 10 tablespoons will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18-50 years old
- •Patients with suspected POTS and healthy volunteers
- •Sedentary healthy subjects of similar age and gender than patients will also be recruited.
- •Only female participants are eligible.
- •Able and willing to provide informed consent
排除标准
- •Overt cause for postural tachycardia, i.e., acute dehydration
- •Significant cardiovascular, pulmonary, hepatic, or hematological disease by history or prior testing
- •Highly trained athletes
- •Subjects with somatization or severe anxiety symptoms will be excluded
- •Pregnant (positive pregnancy test) or breastfeeding
- •Hypertension defined as supine resting BP>145/95 mmHg off medications or needing antihypertensive medication
- •Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
- •Unable to give informed consent
研究组 & 干预措施
All participants
All participants will be administered all procedures as described previously.
Interventions:
Autonomic Function Testing, Posture Study ,Measurement of Total Blood Volume ,Exercise Capacity Test
干预措施: Autonomic Function Testing (Other)
All participants
All participants will be administered all procedures as described previously.
Interventions:
Autonomic Function Testing, Posture Study ,Measurement of Total Blood Volume ,Exercise Capacity Test
干预措施: Posture Study (Other)
All participants
All participants will be administered all procedures as described previously.
Interventions:
Autonomic Function Testing, Posture Study ,Measurement of Total Blood Volume ,Exercise Capacity Test
干预措施: Measurement of Total Blood Volume (Procedure)
All participants
All participants will be administered all procedures as described previously.
Interventions:
Autonomic Function Testing, Posture Study ,Measurement of Total Blood Volume ,Exercise Capacity Test
干预措施: Exercise Capacity Test (Other)
结局指标
主要结局
blood volume deviation (%) from individual predicted volumes
时间窗: 2 days
Compare blood volume deviations using the 131-I-Albumin method. Deviations will be reported as a percentage deviation from an individual's predicted value. These values will be compared between POTS patients and healthy control groups.
次要结局
未报告次要终点
研究者
Alfredo Gamboa
Research Associate Professor of Medicine
Vanderbilt University