Status:
WITHDRAWN
A Study to Systematically Assess the Efficacy and Safety of Intravenous Albumin Infusions in Severe POTS
Lead Sponsor:
University of Alberta
Conditions:
Postural Orthostatic Tachycardia Syndrome
Eligibility:
All Genders
18-69 years
Phase:
PHASE3
Brief Summary
POTS is a relatively common condition that affects millions of patients around the globe. It has an estimated prevalence of 170/100,000 with approximately 80% of patients being women of childbearing a...
Detailed Description
Purpose To assess the efficacy and safety of intravenous 5% albumin infusions in severe Postural Orthostatic Tachycardia Syndrome (POTS). Hypothesis Periodic albumin infusions will be effective in ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03365414
Start Date
January 1 2022
End Date
March 1 2024
Last Update
September 19 2024
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