Trial Outcomes & Findings for Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS) (NCT NCT01764711)
NCT ID: NCT01764711
Last Updated: 2022-03-31
Results Overview
To assess the adrenal responsiveness to adrenocorticotropin hormone (ACTH), as measured by plasma aldosterone level, is contributing to the pathophysiology of Orthostatic Tachycardia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
30 minutes after injection of ACTH
Results posted on
2022-03-31
Participant Flow
Participant milestones
| Measure |
Low Salt Diet POTS
Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.
Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
|
Low Salt Diet Controls
Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.
Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
5
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)
Baseline characteristics by cohort
| Measure |
Low Salt Diet POTS
n=8 Participants
After 7 days of being on a low salt diets, POTS patients and controls will be asked to undergo Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
|
Low Salt Diet Controls
n=5 Participants
After 7 days of being on a low salt diets, POTS patients and controls will be asked to undergo Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 6 • n=5 Participants
|
30 years
STANDARD_DEVIATION 8 • n=7 Participants
|
32 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Baseline Aldosterone
|
34 nanograms/dL
STANDARD_DEVIATION 20.1 • n=5 Participants
|
33 nanograms/dL
STANDARD_DEVIATION 14.2 • n=7 Participants
|
33.5 nanograms/dL
STANDARD_DEVIATION 16.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after injection of ACTHTo assess the adrenal responsiveness to adrenocorticotropin hormone (ACTH), as measured by plasma aldosterone level, is contributing to the pathophysiology of Orthostatic Tachycardia.
Outcome measures
| Measure |
Low Salt Diet POTS
n=8 Participants
Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.
Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
|
Low Salt Diet Controls
n=5 Participants
Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.
Cosyntropin administration: After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
|
|---|---|---|
|
Alldosterone Increase in Response to Adrenocorticotropin Hormone (ACTH).
|
52.5 nanograms/dL
Standard Deviation 15.7
|
57.9 nanograms/dL
Standard Deviation 26.4
|
Adverse Events
Low Salt Diet POTS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Salt Diet Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place