A Study to Systematically Assess the Efficacy and Safety of Intravenous Albumin Infusions in Severe POTS
Postural Orthostatic Tachycardia Syndrome
About this trial
This is an interventional treatment trial for Postural Orthostatic Tachycardia Syndrome focused on measuring Postural Orthostatic Tachycardia Syndrome, POTS, Syncope, Vasovagal, Hypotension, Tachycardia
Eligibility Criteria
Inclusion Criteria:
- Males or females, ages between 18 to 69 years
- Disease duration of >12 months
- Diagnosis of idiopathic POTS confirmed by absolute heart rate increase to >120 beats/minute or increase by >30 beats/minute from baseline within 10 minutes on HUTT without orthostatic hypotension (i.e. drop in systolic BP >30mm of Hg) Plus, • Tachycardia, associated with symptoms of orthostatic intolerance (light-headedness, palpitations, chest pain, nausea, visual blurring, sweating, limb paresthesias)
1. Abnormal sweat testing in the leg/foot (to confirm neuropathic POTS) 2. Severe disease manifestations defined as meeting all three of the following criteria:
- Severe orthostatic intolerance - Orthostatic Symptoms Grading Scale (OSGS) Score >12
- Severe symptoms that preclude activities of daily living i.e. Patient-Reported Outcomes Measurement Information System, Health Assessment Questionnaire (PHAQ 20) score >36
- Lack or limited response to an adequate trial (8 weeks' duration) of at least two of the following standard treatment modalities for POTS including
i. Increased daily intake of salt & water ii. Midodrine iii. Fludrocortisone iv. Beta blockers v. Selective Serotonin Reuptake Inhibitors vi. Desmopressin
Exclusion Criteria:
- Orthostatic hypotension - a decline of 30mm Hg or more in systolic blood pressure or 20mm Hg or more in mean blood pressure within 3 minutes of standing or head-up tilt.
- Abnormal ECG or echocardiogram.
- Recent history (<1 month) of protracted diarrhea or vomiting or hospitalization.
- History of significant psychiatric or eating disorders.
- Pregnancy or lactation.
- History of allergic reactions to human albumin.
- Patients on diuretic, laxative or antihypertensive medications (except beta blockers)
- Systemic illness affecting autonomic function (pheochromocytoma, congestive heart failure, hypertension, renal or hepatic disease, severe anemia, alcoholism, malignant neoplasm, diabetes, hypothyroidism, or stroke).
- Presence of any secondary cause of POTS - amyloidosis, sarcoidosis, alcoholism, lupus, Sjögren's syndrome, chemotherapy, and heavy metal poisoning.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Other
Other
Phase I
Phase II
Placebo ( Normal Saline 0.9% Infusion Solution Bag) or active comparator (Albumin (Human) 5%, USP)
Placebo ( Normal Saline 0.9% Infusion Solution Bag) or active comparator (Albumin (Human) 5%, USP), whichever was not not administered in Phase I