Back to resultsPathophysiology of Orthostatic Intolerance
Primary Purpose
Tachycardia, Postural Orthostatic Tachycardia Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DAXOR
QSweat
Intrinsic Heart Rate
Sponsored by
About this trial
This is an interventional diagnostic trial for Tachycardia focused on measuring heart rate, blood pressure, blood volume, sympathetic nervous system, orthostatic tachycardia, orthostatic intolerance, POTS
Eligibility Criteria
Inclusion Criteria:
- Orthostatic intolerance
Exclusion Criteria:
- Inability or unwillingness to give informed consent
Sites / Locations
- Vanderbilt UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients
Healthy Control Subjects
Arm Description
Patients with orthostatic intolerance
Healthy subjects to determine "normal" response
Outcomes
Primary Outcome Measures
Physiological abnormalities in orthostatic intolerance
Secondary Outcome Measures
blood volume
intrinsic heart rate
quantitative sweat testing
residual sympathetic function after pharmacological autonomic blockade
norepinephrine spillover
Full Information
NCT ID
NCT00608725
First Posted
January 22, 2008
Last Updated
September 20, 2023
Sponsor
Satish R. Raj
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00608725
Brief Title
Pathophysiology of Orthostatic Intolerance
Official Title
Pathophysiology of Orthostatic Intolerance
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1996 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Satish R. Raj
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Postural Orthostatic Tachycardia Syndrome
Keywords
heart rate, blood pressure, blood volume, sympathetic nervous system, orthostatic tachycardia, orthostatic intolerance, POTS
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Other
Arm Description
Patients with orthostatic intolerance
Arm Title
Healthy Control Subjects
Arm Type
Other
Arm Description
Healthy subjects to determine "normal" response
Intervention Type
Radiation
Intervention Name(s)
DAXOR
Other Intervention Name(s)
Volumex
Intervention Description
131-I-Human Serum Albumin Blood Volume Assessment Kit
Intervention Type
Procedure
Intervention Name(s)
QSweat
Other Intervention Name(s)
QSART, Quantitative Axonal Sudomotor Reflex Testing
Intervention Description
Quantitative Sweat Testing
Intervention Type
Drug
Intervention Name(s)
Intrinsic Heart Rate
Other Intervention Name(s)
Inderal, IHR
Intervention Description
Atropine 0.04 mg/kg IV in divided doses Propranolol 0.2 mg/kg IV in divided doses
Primary Outcome Measure Information:
Title
Physiological abnormalities in orthostatic intolerance
Time Frame
1 day
Secondary Outcome Measure Information:
Title
blood volume
Time Frame
1 day
Title
intrinsic heart rate
Time Frame
1 hour
Title
quantitative sweat testing
Time Frame
2 hours
Title
residual sympathetic function after pharmacological autonomic blockade
Time Frame
3 hours
Title
norepinephrine spillover
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Orthostatic intolerance
Exclusion Criteria:
Inability or unwillingness to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bonnie K Black, BSN CNP
Phone
615-343-6499
Email
rajlab@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Robertson, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Robertson, M.D.
First Name & Middle Initial & Last Name & Degree
Italo Biaggioni, MD
First Name & Middle Initial & Last Name & Degree
Satish R Raj, MD MSCI
12. IPD Sharing Statement
Citations:
PubMed Identifier
21266211
Citation
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. doi: 10.1016/j.hrthm.2010.11.009. Epub 2011 Jan 22.
Results Reference
derived
Links:
URL
https://www.vumc.org/autonomic-dysfunction-center/vanderbilt-autonomic-dysfunction
Description
Website of the Vanderbilt Autonomic Dysfunction Center
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Pathophysiology of Orthostatic Intolerance
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