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NCT00608725 Clinical Trial

Pathophysiology of Orthostatic Intolerance

Tachycardia Clinical Trial

Official title:
Pathophysiology of Orthostatic Intolerance

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00608725
Other study ID # 8398
Secondary ID NIH HL56693
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1996
Est. completion date December 2025

Study information
Verified date September 2023
Source Vanderbilt University Medical Center
Contact Bonnie K Black, BSN CNP
Phone 615-343-6499
Email rajlab@vumc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Orthostatic intolerance Exclusion Criteria: - Inability or unwillingness to give informed consent

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Vanderbilt University Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Satish R. Raj National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physiological abnormalities in orthostatic intolerance 1 day
Secondary blood volume 1 day
Secondary intrinsic heart rate 1 hour
Secondary quantitative sweat testing 2 hours
Secondary residual sympathetic function after pharmacological autonomic blockade 3 hours
Secondary norepinephrine spillover 3 hours
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