Postural Orthostatic Tachycardia Syndrome (POTS)
Conditions
Keywords
POTS, Orthostatic intolerance
Brief 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.
Interventions
DRUGAngiotensin II
Angiotensin II infusion for 1 hour
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Blood Pressure Change | 1 hour | Change in MAP from baseline to after 1h of infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Renin Activity | 1 hour | Change in plasma renin activity from baseline to after 1h of infusion. |
| Aldosterone Level | 1 hour | Change in aldosterone blood level from baseline to after 1h of infusion. |
| Cortisol Level | 1 hour | Change in cortisol blood level from baseline to after 1h of infusion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Healthy controls
Angiotensin II: Angiotensin II infusion for 1 hour | 13 |
| Postural Tachycardia Syndrome Patients with Postural Tachycardia Syndrome
Angiotensin II: Angiotensin II infusion for 1 hour | 15 |
| Total | 28 |
Baseline characteristics
| Characteristic | Total | Control | Postural Tachycardia Syndrome |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 13 Participants | 15 Participants |
| Region of Enrollment United States | 28 Participants | 13 Participants | 15 Participants |
| Sex: Female, Male Female | 28 Participants | 13 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 15 |
| other Total, other adverse events | 0 / 13 | 0 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 |
Outcome results
Primary
Mean Arterial Blood Pressure Change
Change in MAP from baseline to after 1h of infusion.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Mean Arterial Blood Pressure Change | 14 mmHg | Standard Error 1 |
| Postural Tachycardia Syndrome | Mean Arterial Blood Pressure Change | 10 mmHg | Standard Error 1 |
Secondary
Aldosterone Level
Change in aldosterone blood level from baseline to after 1h of infusion.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Aldosterone Level | 15 picogram/milliliter | Standard Error 2 |
| Postural Tachycardia Syndrome | Aldosterone Level | 17 picogram/milliliter | Standard Error 1 |
Secondary
Cortisol Level
Change in cortisol blood level from baseline to after 1h of infusion.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Cortisol Level | -1.4 ng/ml/h | Standard Error 0.6 |
| Postural Tachycardia Syndrome | Cortisol Level | -0.7 ng/ml/h | Standard Error 0.6 |
Secondary
Plasma Renin Activity
Change in plasma renin activity from baseline to after 1h of infusion.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Plasma Renin Activity | -0.6 micrograms/deciliter | Standard Error 0.2 |
| Postural Tachycardia Syndrome | Plasma Renin Activity | -0.9 micrograms/deciliter | Standard Error 0.2 |