Hemodynamic Response of Neuropathic And Non-Neuropathic POTS Patients To Adrenoreceptor Agonist And Antagonist

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance

In brief

The purpose of this study is to test the hypothesis that patients with non-neuropathic POTS will have different responsiveness than patients with neuropathic POTS to direct alpha-1 adrenoreceptor agonist therapy (droxidopa) and to non-selective beta-adrenoreceptor antagonist therapy (atenolol). The specific goal of this protocol is to investigate the effect of atenolol and droxidopa on cardiovascular autonomic functions such as cardiovagal control, sympathetic nerve activity, and sympathetic vascular transduction, systemic hemodynamic response to orthostatic stress and on the quality of life in neuropathic and non-neuropathic patients with postural tachycardia syndrome (POTS). Standardized tests are used to assess cardiovagal control function, sympathetic nerve activity, sympathetic vascular transduction, systemic hemodynamic response to head-up tilt test and standardized questionnaires to assess the quality of life in patients with POTS. The cardiovagal, sympathetic and hemodynamic measurements are performed after and during drug administration. To control the effect of medications placebo is used on separate testing visits. The order of drugs and placebo is randomized.

Key facts

Study ID

NCT03070730

Run by

Beth Israel Deaconess Medical Center

People needed

8

Starts

2011-08-15

Expected to finish

2014-07-28

Last updated by the study team

2017-05-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CDC criteria for chronic fatigue syndrome
• Evidence of postural tachycardia syndrome with symptoms of orthostatic intolerance

You may not qualify if…

• Pregnant or lactating females. The administration of droxidopa is harmful to the fetus
• Concomitant therapy with anticholinergic, alpha-, and beta-adrenergic antagonists or other medications that affect autonomic function
• Clinically significant coronary artery, cerebrovascular or peripheral vascular disease
• Cardiac arrhythmias
• Systemic illness that might affect autonomic function such as congestive heart failure, hypertension, renal, pulmonary, and hepatic disease, anemia, malignancies, thyroid disease, and alcoholism
• Severe depression, severe anxiety disorder (score of on the Beck Depression Inventory > 29 or score on the Beck Anxiety Inventory of ≥ 36) or psychosis
• Antidepressant treatment by MAO inhibitors within 2 weeks before the study
• Glaucoma
• Liver disease
• Subjects with a history of reaction to local anesthetic will be excluded from the study
• Subjects who have a history of any bleeding disorders or significantly impaired wound healing will be excluded. Subjects who are using any medications such as Coumadin or Plavix will be also excluded
• Subjects who are currently enrolled in any other studies using investigational products

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Center for Autonomic and Peripheral Nerve Disorders - Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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