The Renin-Aldosterone Axis in Postural Tachycardia Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00962949
First received: August 18, 2009
Last updated: August 19, 2009
Last verified: August 2009
  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 Tachycardia Syndrome
Drug: Angiotensin II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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:

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

Secondary Outcome Measures:
  • Differences in blood volume hormones responses between patients and healthy volunteers [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: April 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962949

Contacts
Contact: Bonnie Black, RN 615-343-6862 bonnie.black@Vanderbilt.Edu
Contact: Ginnie Farley, RA 615-322-0083 ginnie.farley@Vanderbilt.Edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: David Robertson, MD         
Sub-Investigator: Hossam Mustafa, MD         
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hossam Mustafa MD, Vanderbilt University school Of Medicine
ClinicalTrials.gov Identifier: NCT00962949     History of Changes
Other Study ID Numbers: 081398, PF334
Study First Received: August 18, 2009
Last Updated: August 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
POTS
Orthostatic intolerance

Additional relevant MeSH terms:
Orthostatic Intolerance
Syndrome
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Angiotensin II
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014