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The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962949
First Posted: August 20, 2009
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vanderbilt University Medical Center
  Purpose
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.

Condition Intervention
Postural Orthostatic Tachycardia Syndrome (POTS) Drug: Angiotensin II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

Resource links provided by NLM:


Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Difference in blood pressure rise between patients and healthy volunteers [ Time Frame: 1 hour ]

Secondary Outcome Measures:
  • Differences in blood volume hormones responses between patients and healthy volunteers [ Time Frame: 1 hour ]

Enrollment: 35
Study Start Date: April 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Healthy controls
Drug: Angiotensin II
Angiotensin II infusion for 1 hour
Experimental: 2
Patients
Drug: Angiotensin II
Angiotensin II infusion for 1 hour

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962949


Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by Vanderbilt University Medical Center:
POTS
Orthostatic intolerance

Additional relevant MeSH terms:
Syndrome
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Angiotensin II
Angiotensinogen
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action