N/A
N=27
Effect of Dietary Sodium Intake on Vascular Endothelium
Postural Tachycardia Syndrome (POTS)
Bottom Line
View on ClinicalTrials.gov: NCT01550315 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: FMD (% Change) — 12.75; 11.65; 11.43; 12.75 percentage of change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pulsitile Arterial Tonometry (PAT) Protocol (Procedure); Calf Blood Flow in Reactive Hyperemia (CBF-RH) (Device); Evaluation of Forearm-Mediated Dilation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FMD (% Change) |
12.75; 11.65; 11.43; 12.75 | — |
Summary
The investigators will test the hypothesis that markers of vascular endothelial dysfunction will be exaggerated acutely with an extreme high sodium diet compared to an extreme low-sodium diet. The investigators will compare patients with postural orthostatic tachycardia (POTS) to healthy control subjects.
Eligibility Criteria
Inclusion Criteria
- Subjects will be enrolled in the parent study "Dietary Salt in Postural Tachcyardia Syndrome" funded by R01 HL102387 Postural Tachycardia Syndrome
- Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
- Subjects will be enrolled in the parent study "Dietary Salt in Postural Tachcyardia Syndrome" funded by R01 HL102387
- Postural Tachycardia Syndrome
- 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 Control Subjects
- Healthy, non-obese, non-smokers without orthostatic tachycardia
- Selected to match profiles of POTS patients (gender, age)
- Not using vasoactive medication
- Age between 18-60 years
- Male and female subjects are eligible.
- Able and willing to provide informed consent
Exclusion Criteria
- Overt cause for postural tachycardia (such as acute dehydration)
- Inability to give, or withdrawal of, informed consent
- Pregnant
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
Data sourced from ClinicalTrials.gov (NCT01550315). 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.