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The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

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ClinicalTrials.gov Identifier: NCT00962949
Recruitment Status : Completed
First Posted : August 20, 2009
Results First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Postural Orthostatic Tachycardia Syndrome (POTS)
Intervention Drug: Angiotensin II
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Postural Tachycardia Syndrome
Hide Arm/Group Description

Healthy controls

Angiotensin II: Angiotensin II infusion for 1 hour

Patients with Postural Tachycardia Syndrome

Angiotensin II: Angiotensin II infusion for 1 hour

Period Title: Overall Study
Started 13 15
Completed 13 15
Not Completed 0 0
Arm/Group Title Control Postural Tachycardia Syndrome Total
Hide Arm/Group Description

Healthy controls

Angiotensin II: Angiotensin II infusion for 1 hour

Patients with Postural Tachycardia Syndrome

Angiotensin II: Angiotensin II infusion for 1 hour

Total of all reporting groups
Overall Number of Baseline Participants 13 15 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
15
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 15 participants 28 participants
Female
13
 100.0%
15
 100.0%
28
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 15 participants 28 participants
13 15 28
1.Primary Outcome
Title Mean Arterial Blood Pressure Change
Hide Description [Not Specified]
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Postural Tachycardia Syndrome
Hide Arm/Group Description:

Healthy controls

Angiotensin II: Angiotensin II infusion for 1 hour

Patients with Postural Tachycardia Syndrome

Angiotensin II: Angiotensin II infusion for 1 hour

Overall Number of Participants Analyzed 13 15
Mean (Standard Error)
Unit of Measure: mm/Hg
14  (1) 10  (1)
2.Secondary Outcome
Title Plasma Renin Activity
Hide Description [Not Specified]
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Postural Tachycardia Syndrome
Hide Arm/Group Description:

Healthy controls

Angiotensin II: Angiotensin II infusion for 1 hour

Patients with Postural Tachycardia Syndrome

Angiotensin II: Angiotensin II infusion for 1 hour

Overall Number of Participants Analyzed 13 15
Mean (Standard Error)
Unit of Measure: micrograms/deciliter
-0.6  (.2) -0.9  (0.2)
3.Secondary Outcome
Title Aldosterone Level
Hide Description [Not Specified]
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Postural Tachycardia Syndrome
Hide Arm/Group Description:

Healthy controls

Angiotensin II: Angiotensin II infusion for 1 hour

Patients with Postural Tachycardia Syndrome

Angiotensin II: Angiotensin II infusion for 1 hour

Overall Number of Participants Analyzed 13 15
Mean (Standard Error)
Unit of Measure: picogram/milliliter
15  (2) 17  (1)
4.Secondary Outcome
Title Cortisol Level
Hide Description [Not Specified]
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Postural Tachycardia Syndrome
Hide Arm/Group Description:

Healthy controls

Angiotensin II: Angiotensin II infusion for 1 hour

Patients with Postural Tachycardia Syndrome

Angiotensin II: Angiotensin II infusion for 1 hour

Overall Number of Participants Analyzed 13 15
Mean (Standard Error)
Unit of Measure: ng/ml/h
-1.4  (0.6) -0.7  (0.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Postural Tachycardia Syndrome
Hide Arm/Group Description

Healthy controls

Angiotensin II: Angiotensin II infusion for 1 hour

Patients with Postural Tachycardia Syndrome

Angiotensin II: Angiotensin II infusion for 1 hour

All-Cause Mortality
Control Postural Tachycardia Syndrome
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Postural Tachycardia Syndrome
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Postural Tachycardia Syndrome
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hossam Mustafa
Organization: Vanderbilt University Medical Center
EMail: adcresearch@vanderbilt.edu
Layout table for additonal information
Responsible Party: Satish R. Raj, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00962949     History of Changes
Other Study ID Numbers: 081398
PF334
First Submitted: August 18, 2009
First Posted: August 20, 2009
Results First Submitted: November 16, 2017
Results First Posted: August 17, 2018
Last Update Posted: August 17, 2018