A Randomized Study of Protein A Immunoadsorption Therapy for Adults with Dilated Cardiomyopathy to Assess Safety and Effectiveness

What this Trial Is About

Researchers are conducting a multicenter, randomized controlled clinical trial to study patients with dilated cardiomyopathy who have positive beta-1 adrenergic receptor autoantibodies. The trial aims to evaluate and compare the effects of immunoadsorption therapy on heart function, heart structure, and clinical outcomes. Sixty patients aged 18 to 75 years with specific heart failure symptoms and stable medical treatment are being studied to better understand this potential treatments impact. Participants are randomly assigned to one of two groups one receiving immunoadsorption therapy using a protein A column for four consecutive days followed by immunoglobulin supplementation, and a control group that does not receive immunoadsorption therapy. This therapy is studied as a procedure. The study monitors patients for changes in heart function and symptoms over time, specifically following up at 3, 6, 12, and 24 months. During the trial, participants undergo regular assessments including echocardiography to measure heart function and size, symptom classification, questionnaires about their heart failure impact, and blood tests for heart failure markers. The primary outcome is the change in left ventricular ejection fraction LVEF at 6 months, with additional outcomes tracked up to 24 months. Researchers also monitor safety and clinical status throughout the study, which lasts up to two years after enrollment.

Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)