The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

November 16, 2017 updated by: Satish R. Raj, Vanderbilt University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
Healthy controls
Drug: Angiotensin II
Angiotensin II infusion for 1 hour
Experimental: Postural Tachycardia Syndrome
Patients with Postural Tachycardia Syndrome
Drug: Angiotensin II
Angiotensin II infusion for 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Arterial Blood Pressure Change
Time Frame: 1 hour
1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma Renin Activity
Time Frame: 1 hour
1 hour
Aldosterone Level
Time Frame: 1 hour
1 hour
Cortisol Level
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 18, 2009

First Submitted That Met QC Criteria

August 19, 2009

First Posted (Estimate)

August 20, 2009

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 081398
  • PF334

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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