NCT00962949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

August 17, 2018

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

3.7 years

First QC Date

August 18, 2009

Results QC Date

November 16, 2017

Last Update Submit

September 3, 2025

Conditions

Keywords

POTSOrthostatic intolerance

Outcome Measures

Primary Outcomes (1)

  • Mean Arterial Blood Pressure Change

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

    1 hour

Secondary Outcomes (3)

  • Plasma Renin Activity

    1 hour

  • Aldosterone Level

    1 hour

  • Cortisol Level

    1 hour

Study Arms (2)

Control

EXPERIMENTAL

Healthy controls

Drug: Angiotensin II

Postural Tachycardia Syndrome

EXPERIMENTAL

Patients with Postural Tachycardia Syndrome

Drug: Angiotensin II

Interventions

Angiotensin II infusion for 1 hour

ControlPostural Tachycardia Syndrome

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Mustafa HI, Raj SR, Diedrich A, Black BK, Paranjape SY, Dupont WD, Williams GH, Biaggioni I, Robertson D. Altered systemic hemodynamic and baroreflex response to angiotensin II in postural tachycardia syndrome. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):173-80. doi: 10.1161/CIRCEP.111.965343. Epub 2012 Jan 13.

MeSH Terms

Conditions

Postural Orthostatic Tachycardia SyndromeOrthostatic Intolerance

Interventions

Angiotensin II

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AngiotensinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsAutacoidsInflammation MediatorsBiological Factors

Limitations and Caveats

This was a single center, acute study.

Results Point of Contact

Title
Hossam Mustafa
Organization
Vanderbilt University Medical Center

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Assoc Professor

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 20, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 16, 2025

Results First Posted

August 17, 2018

Record last verified: 2025-09

Locations