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:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
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 Sweat

Drug Information available for: Propranolol

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 2013
Estimated Primary Completion Date:	December 2013 (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 Other Name: Volumex Procedure: QSweat Quantitative Sweat Testing Other Names: QSART Quantitative Axonal Sudomotor Reflex Testing Drug: Intrinsic Heart Rate Atropine 0.04 mg/kg IV in divided doses Propranolol 0.2 mg/kg IV in divided doses Other Names: Inderal IHR
Healthy Control Subjects Healthy subjects to determine "normal" response	Radiation: DAXOR 131-I-Human Serum Albumin Blood Volume Assessment Kit Other Name: Volumex Procedure: QSweat Quantitative Sweat Testing Other Names: QSART Quantitative Axonal Sudomotor Reflex Testing Drug: Intrinsic Heart Rate Atropine 0.04 mg/kg IV in divided doses Propranolol 0.2 mg/kg IV in divided doses Other Names: Inderal IHR

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 by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mustafa HI, Garland EM, Biaggioni I, Black BK, Dupont WD, Robertson D, Raj SR. Abnormalities of angiotensin regulation in postural tachycardia syndrome. Heart Rhythm. 2011 Mar;8(3):422-8. Epub 2011 Jan 22.

Responsible Party:	David Robertson, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00608725 History of Changes
Other Study ID Numbers:	8398, NIH HL56693
Study First Received:	January 22, 2008
Last Updated:	June 24, 2011
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:

Orthostatic Intolerance
Mitral Valve Prolapse
Neurocirculatory Asthenia
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations

Signs and Symptoms
Heart Valve Prolapse
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Anxiety Disorders
Mental Disorders
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012