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Enrolling By Invitation NCT06635863

Comparing Immune System Suppression to Medication for Unexplained Heart Function and Irregular Heartbeat

Conditions: Ventricular Arrythmia, Non-ischemic Cardiomyopathy, Arrhythmogenic Inflammatory Cardiomyopathy

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 40
Sponsor: Roderick Tung

Location: Banner - University Medical Center, Phoenix campus Phoenix Arizona

Summary

Ventricular tachycardia (VT, a potentially fatal condition where the ventricle of the heart beats rapidly) superimposed on non-ischemic cardiomyopathy (NICM, a disease of heart with broad etiologies except coronary artery disease). This disease has been associated with inflammation in the heart. The purpose of this study is to assess the benefit of immunosuppressive therapy to suppress the VT, improve heart function, avoid invasive intervention and hospitalization. Positron Emission Tomography (PET) imaging shows inflammation in the heart. After enrollment, baseline tests (including physical exams, blood tests, genetic test, electrocardiography, echocardiography) will be done. Next, will be an 8-week medication regimen which contains either immunosuppressive drugs or standard GDMT without immunosuppressant medication. Some of the examinations will be repeated during the study to evaluate the treatment response and monitor any adverse events.

Eligibility Criteria

Inclusion Criteria: * 18 years of age, all races, all gender * LV systolic function \< 50% * Optimized GDMT Per physicians' discretion (SOC treatment) * No evidence of ischemic cardiomyopathy * No evidence of obstructive coronary disease * Viral panel negative * NYHA class II, III and ambulatory class IV heart failure * History of VA (documentation of Sustained VT last more than 30 seconds) * Heart inflammation confirmed by PET scan * Steroid use within 12 months prior to of date of consent Exclusion Criteria: * Life expectancy less than 24 months * Pregnancy * Contra indications or intolerance of prednisone or any excipients in the formulation * Hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, active infection, glaucoma or any other pathology where corticosteroids are not recommended. * Any patient with HIV, low white blood cells, and chronic infection (active fungal, TB, Valley fever)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06635863). StuddyBuddy aggregates publicly available trial information.