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The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

Primary Purpose

Postural Orthostatic Tachycardia Syndrome (POTS)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Angiotensin II
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postural Orthostatic Tachycardia Syndrome (POTS) focused on measuring POTS, Orthostatic intolerance

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

Postural Tachycardia Syndrome

Arm Description

Healthy controls

Patients with Postural Tachycardia Syndrome

Outcomes

Primary Outcome Measures

Mean Arterial Blood Pressure Change

Secondary Outcome Measures

Plasma Renin Activity
Aldosterone Level
Cortisol Level

Full Information

First Posted
August 18, 2009
Last Updated
November 16, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00962949
Brief Title
The Renin-Aldosterone Axis in Postural Tachycardia Syndrome
Official Title
The Renin-Aldosterone Axis in Postural Tachycardia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Orthostatic Tachycardia Syndrome (POTS)
Keywords
POTS, Orthostatic intolerance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Healthy controls
Arm Title
Postural Tachycardia Syndrome
Arm Type
Experimental
Arm Description
Patients with Postural Tachycardia Syndrome
Intervention Type
Drug
Intervention Name(s)
Angiotensin II
Intervention Description
Angiotensin II infusion for 1 hour
Primary Outcome Measure Information:
Title
Mean Arterial Blood Pressure Change
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Plasma Renin Activity
Time Frame
1 hour
Title
Aldosterone Level
Time Frame
1 hour
Title
Cortisol Level
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22247480
Citation
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.
Results Reference
derived

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The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

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