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Pathophysiology of Orthostatic Intolerance

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00608725
Recruitment Status : Recruiting
First Posted : February 6, 2008
Last Update Posted : September 15, 2022
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE January 22, 2008
First Posted Date  ICMJE February 6, 2008
Last Update Posted Date September 15, 2022
Study Start Date  ICMJE December 1996
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2008)		 Physiological abnormalities in orthostatic intolerance [ Time Frame: 1 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
  • blood volume [ Time Frame: 1 day ]
  • intrinsic heart rate [ Time Frame: 1 hour ]
  • quantitative sweat testing [ Time Frame: 2 hours ]
  • residual sympathetic function after pharmacological autonomic blockade [ Time Frame: 3 hours ]
  • norepinephrine spillover [ Time Frame: 3 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pathophysiology of Orthostatic Intolerance
Official Title  ICMJE Pathophysiology of Orthostatic Intolerance
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Tachycardia
  • Postural Orthostatic Tachycardia Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Patients
    Patients with orthostatic intolerance
    Interventions:
    • Radiation: DAXOR
    • Procedure: QSweat
    • Drug: Intrinsic Heart Rate
  • Healthy Control Subjects
    Healthy subjects to determine "normal" response
    Interventions:
    • Radiation: DAXOR
    • Procedure: QSweat
    • Drug: Intrinsic Heart Rate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2008)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Orthostatic intolerance

Exclusion Criteria:

  • Inability or unwillingness to give informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Bonnie K Black, BSN CNP 615-343-6499 rajlab@vumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00608725
Other Study ID Numbers  ICMJE 8398
NIH HL56693
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Satish R. Raj, Vanderbilt University Medical Center
Original Responsible Party David Robertson, Vanderbilt University
Current Study Sponsor  ICMJE Satish R. Raj
Original Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: David Robertson, MD Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP