Pathophysiology of Orthostatic Intolerance - Full Text View

Sponsor:	Vanderbilt University
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00608725

Purpose

The purpose of this study is to describe the mechanism of orthostatic intolerance, relying on cardiovascular physiological studies. The syndrome is of undetermined etiology, but the syndrome causes impairment of a number of young adults, females more than males, with symptoms of tachycardia, fatigue, lightheadedness, palpitations, blurred vision, chest discomfort, difficulty concentrating, and dizziness with the upright posture. It is believed that many different pathophysiological processes can give rise to this disorder.

Condition	Intervention
Tachycardia Postural Orthostatic Tachycardia Syndrome	Radiation: DAXOR Procedure: QSweat Drug: Intrinsic Heart Rate

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Pathophysiology of Orthostatic Intolerance

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Mitral Valve Prolapse Mobility Aids

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Physiological abnormalities in orthostatic intolerance [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

blood volume [ Time Frame: 1 day ] [ Designated as safety issue: No ]
intrinsic heart rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
quantitative sweat testing [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
residual sympathetic function after pharmacological autonomic blockade [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
norepinephrine spillover [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 1996
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Patients Patients with orthostatic intolerance	Radiation: DAXOR 131-I-Human Serum Albumin Blood Volume Assessment Kit Procedure: QSweat Quantitative Sweat Testing Drug: Intrinsic Heart Rate Atropine 0.04 mg/kg IV in divided doses Propranolol 0.2 mg/kg IV in divided doses
Healthy Control Subjects Healthy subjects to determine "normal" response	Radiation: DAXOR 131-I-Human Serum Albumin Blood Volume Assessment Kit Procedure: QSweat Quantitative Sweat Testing Drug: Intrinsic Heart Rate Atropine 0.04 mg/kg IV in divided doses Propranolol 0.2 mg/kg IV in divided doses

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Orthostatic intolerance

Exclusion Criteria:

Inability or unwillingness to give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608725

Contacts

Contact: Bonnie K Black, BSN CNP

615-343-6499

adc.research@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: David Robertson, M.D.
Sub-Investigator: Italo Biaggioni, MD
Sub-Investigator: Satish R Raj, MD MSCI

Sponsors and Collaborators

Vanderbilt University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

David Robertson, MD

Vanderbilt University

More Information

Additional Information:

Website of the Vanderbilt Autonomic Dysfunction Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Vanderbilt University ( David Robertson )
Study ID Numbers:	8398, NIH HL56693
Study First Received:	January 22, 2008
Last Updated:	September 1, 2009
ClinicalTrials.gov Identifier:	NCT00608725 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

heart rate
blood pressure
blood volume
sympathetic nervous system

orthostatic tachycardia
orthostatic intolerance
POTS

Additional relevant MeSH terms:

Heart Diseases
Disease
Tachycardia
Heart Valve Diseases
Pathologic Processes
Anxiety Disorders
Mitral Valve Prolapse

Mental Disorders
Syndrome
Cardiovascular Diseases
Neurocirculatory Asthenia
Heart Valve Prolapse
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010