A Study to Systematically Assess the Efficacy and Safety of Intravenous Albumin Infusions in Severe POTS
Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
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 age. POTS is characterized by an excessive heart rate increase on assuming an
upright posture, either standing or even sitting and leading to disabling palpitations,
light-headedness, and even in syncope in severe cases. More than 95% patients with POTS have
pronounced cardiovascular deconditioning and show marked exercise intolerance. The severity
of POTS is variable. In mild cases the affected patient may continue with routine activities
with minimal limitations. Severe form of the disease precludes most normal life activities,
such as sitting upright, walking or standing to perform even basic house chores. An estimated
40% of patients with POTS have a resistant form of the condition that is nonresponsive or
mildly responsive to all treatments resulting in continued functional limitations in the long
term.
Many of the currently available treatments in POTS are geared towards increasing blood
pressure. These include compression stockings, increased daily fluid intake and increased
salt ingestion. Saline infusions may be helpful in certain patients in the short term, though
many do not respond. The effectiveness of medications varies greatly, with many patient
failing to improve.
A small series of clinical patients suffering from severe POTS have shown robust response to
weekly albumin therapy, which supports the hypothesis that periodic albumin infusions will
provide significant and sustained symptomatic relief to patients with severe POTS.
This pilot study will explore the effectiveness of albumin infusions as a treatment for POTS.
Eligible patients will receive weekly intravenous infusions of 5% Albumin or Saline in a
double blinded fashion for 4 weeks and will crossover to the other infusion for 4 weeks after
an intervening 4-week washout period. The participants will be required to maintain a daily
diary of their symptoms during the screening, the study and washout periods. Any possible
adverse effects as the result of infusions will be documented. Outcome measures will be
quantified and validated at the end of each study period and the percentage reduction of
tachycardia will be determined at the completion of each study arm.