Hemodynamic Response of Neuropathic And Non-Neuropathic POTS Patients To Adrenoreceptor Agonist And Antagonist
Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance
About this trial
This is an interventional treatment trial for Postural Orthostatic Tachycardia Syndrome focused on measuring Tachycardia, orthostatic symptoms, autonomic reflex
Eligibility Criteria
Inclusion Criteria:
- CDC criteria for chronic fatigue syndrome
- Evidence of postural tachycardia syndrome with symptoms of orthostatic intolerance
Exclusion Criteria:
- 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
Sites / Locations
- Beth Israel Deaconess Medical Center
- Center for Autonomic and Peripheral Nerve Disorders - Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
Atenolol
Placebos
Droxidopa
In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid. Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients. Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.
In this arm subjects are randomized to placebo tid. Placebo is used to control the administration effect.
In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid. Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients. Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.