Aldosterone & Sodium Regulation in Postural Tachycardia Syndrome - Screening
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Postural Tachycardia Syndrome |
Other: Autonomic Function Testing Other: Posture Study Procedure: Measurement of Total Blood Volume Other: Exercise Capacity Test |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome - Screening Protocol |
- blood volume deviation (%) from individual predicted volumes [ Time Frame: 2 days ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 110 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Other: Autonomic Function Testing
heart rate and blood pressure will be continuously monitored while participants undergo a variety of breathing techniques (deep breathing, rapid breathing, blowing against resistance) and during sustained handgrip and cold pressor (hand in ice water). All tests are meant to stimulate the autonomic nervous system to produce changes in blood pressure and heart rate of short duration that reflect how well the autonomic nervous system is functioning. Also during autonomic function testing, cardiac output will be measured to analyze the shift of fluids in the body (body impedance) and / or by analyzing the air that is breathed. Blood pressure, heart rate and blood samples (for catecholamines and hormones) will be measured & collected in the supine (lying) and upright position for each participant.
Other Name: Supine & standing blood pressure, heart rate & blood draws.
Procedure: Measurement of Total Blood Volume
Total blood volume is measured by using iodinated I-131 tagged human serum albumin.
Other Names:
Other: Exercise Capacity Test
Participants will ride on a stationary recumbent bicycle and the resistance will be gradually increased while expired air is measured.
Other Name: Masimal Oxygen Consumption Test
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Smokers
- 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
Contacts and Locations| Contact: Satish Raj, MD, MSCI | 615-322-2931 | adcresearch@vanderbilt.edu |
| Contact: Victor Nwazue, MD | 615-322-3304 | adcresearch@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Satish Raj, MD, MSCI 615-322-2931 adcresearch@vanderbilt.edu | |
| Contact: Victor Nwazue, MD 615-322-3304 adcresearch@vanderbilt.edu | |
| Principal Investigator: Satish Raj, MD, MSCI | |
| Sub-Investigator: Victor Nwazue, MD | |
| Principal Investigator: | Satish Raj, MD, MSCI | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | Satish R. Raj, Assistant Professor, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01783288 History of Changes |
| Other Study ID Numbers: | IRB 121817 |
| Study First Received: | January 25, 2013 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
Postural tachycardia syndrome orthostatic intolerance orthostatic tachycardia POTS |
Additional relevant MeSH terms:
|
Tachycardia Postural Orthostatic Tachycardia Syndrome Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases |
Pathologic Processes Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013