Phase 1
N=28
The Renin-Aldosterone Axis in Postural Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome (POTS)
Bottom Line
View on ClinicalTrials.gov: NCT00962949 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Mean Arterial Blood Pressure Change — 14; 10 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Angiotensin II (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Arterial Blood Pressure Change |
14; 10 | — |
| SECONDARY Plasma Renin Activity |
-0.6; -0.9 | — |
| SECONDARY Aldosterone Level |
15; 17 | — |
| SECONDARY Cortisol Level |
-1.4; -0.7 | — |
Summary
The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in the pathophysiology of postural tachycardia syndrome, and to provide an insight about the disease process in this disorder.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center criteria
- Age between 18-64 years
- Male or females are eligible
- Able and willing to provide informed consent
- Healthy control subjects with no major medical problem (including postural tachycardia syndrome), free of medications during the study
Exclusion Criteria
- Overt cause of postural tachycardia e.g., dehydration
- Inability to give or withdraw informed consent
- Pregnancy
- Hypertension (BP > 140/90)
- Significant co-morbid condition
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol
Data sourced from ClinicalTrials.gov (NCT00962949). 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.