Trial Outcomes & Findings for The Renin-Aldosterone Axis in Postural Tachycardia Syndrome (NCT NCT00962949)

NCT ID: NCT00962949

Last Updated: 2025-09-16

Results Overview

Change in MAP from baseline to after 1h of infusion.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 28 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2025-09-16

Participant Flow

Participant milestones

Measure	Control Healthy controls Angiotensin II: Angiotensin II infusion for 1 hour	Postural Tachycardia Syndrome Patients with Postural Tachycardia Syndrome Angiotensin II: Angiotensin II infusion for 1 hour
Overall Study STARTED	13	15
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

Baseline characteristics by cohort

Measure	Control n=13 Participants Healthy controls Angiotensin II: Angiotensin II infusion for 1 hour	Postural Tachycardia Syndrome n=15 Participants Patients with Postural Tachycardia Syndrome Angiotensin II: Angiotensin II infusion for 1 hour	Total n=28 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	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Change in MAP from baseline to after 1h of infusion.

Outcome measures

Measure	Control n=13 Participants Healthy controls Angiotensin II: Angiotensin II infusion for 1 hour	Postural Tachycardia Syndrome n=15 Participants Patients with Postural Tachycardia Syndrome Angiotensin II: Angiotensin II infusion for 1 hour
Mean Arterial Blood Pressure Change	14 mmHg Standard Error 1	10 mmHg Standard Error 1

SECONDARY outcome

Timeframe: 1 hour

Change in plasma renin activity from baseline to after 1h of infusion.

Outcome measures

Measure	Control n=13 Participants Healthy controls Angiotensin II: Angiotensin II infusion for 1 hour	Postural Tachycardia Syndrome n=15 Participants Patients with Postural Tachycardia Syndrome Angiotensin II: Angiotensin II infusion for 1 hour
Plasma Renin Activity	-0.6 micrograms/deciliter Standard Error .2	-0.9 micrograms/deciliter Standard Error 0.2

SECONDARY outcome

Timeframe: 1 hour

Change in aldosterone blood level from baseline to after 1h of infusion.

Outcome measures

Measure	Control n=13 Participants Healthy controls Angiotensin II: Angiotensin II infusion for 1 hour	Postural Tachycardia Syndrome n=15 Participants Patients with Postural Tachycardia Syndrome Angiotensin II: Angiotensin II infusion for 1 hour
Aldosterone Level	15 picogram/milliliter Standard Error 2	17 picogram/milliliter Standard Error 1

SECONDARY outcome

Timeframe: 1 hour

Change in cortisol blood level from baseline to after 1h of infusion.

Outcome measures

Measure	Control n=13 Participants Healthy controls Angiotensin II: Angiotensin II infusion for 1 hour	Postural Tachycardia Syndrome n=15 Participants Patients with Postural Tachycardia Syndrome Angiotensin II: Angiotensin II infusion for 1 hour
Cortisol Level	-1.4 ng/ml/h Standard Error 0.6	-0.7 ng/ml/h Standard Error 0.6

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Postural Tachycardia Syndrome

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

Hossam Mustafa

Vanderbilt University Medical Center

Phone: 615-343-6499

Email: adcresearch@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place