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A Study to Systematically Assess the Efficacy and Safety of Intravenous Albumin Infusions in Severe POTS

NCT03365414 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Postural Orthostatic Tachycardia Syndrome

Interventions

BIOLOGICAL

Albumin (Human) 5%, USP

Albumin (Human) 5%, USP. Intravenous Solution. Plasma Substitute/Blood Derivative

DRUG

Normal Saline 0.9% Infusion Solution Bag

Placebo Normal Saline 0.9% Infusion Solution Bag.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Zaeem Siddiqi, MD PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-10-31
Completion
2024-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03365414 on ClinicalTrials.gov