N/A
N=38
Dietary Salt in Postural Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01547117 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Plasma Volume — 2805; 3032; 2362; 2633 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood Volume (Radiation); Total Blood Volume (Radiation); Exercise Capacity Test - Bicycle (Procedure); Posture Study (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Volume |
2805; 3032; 2362; 2633 | — |
| SECONDARY Magnitude of Suppression of Plasma Renin Activity (From Low Sodium to High Sodium Diets) |
7.8; 1.0; 24.4; 2.7 | — |
Summary
Patients with POTS may not adequately expand their plasma volume in response to a high-sodium (Na+) diet. Mechanisms involved in the regulation of plasma volume, such as the renin-angiotensin-aldosterone system and renal dopamine, may be impaired in POTS and may respond inappropriately to changes in dietary sodium.The purpose of this study is to determine (1) whether a high dietary sodium level appropriately expands plasma volume in POTS; (2) whether plasma renin activity and aldosterone are modified appropriately by changes in dietary sodium in POTS; and (3) whether patients with POTS have improvements in their orthostatic tachycardia and symptoms as a result of a high dietary sodium level.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
- Increase in heart rate ≥30 beats/min with position change from supine to standing (10 minutes)
- Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
- Age between 18-50 years old
- Non-smokers
- Premenopausal patients with POTS and healthy volunteers
- Only female participants are eligible.
- Since 80-90% of POTS patients are female, and there can be differences in measures with the menstrual cycle, including a small number of males might introduce a significant amount of noise.
- 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 screening results
- 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
Data sourced from ClinicalTrials.gov (NCT01547117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.