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

Launched by RODERICK TUNG · Oct 8, 2024

Keywords

ClinConnect Summary

Ventricular arrhythmia (VT) is a well-established consequence in patients with non-ischemic cardiomyopathy (NICM). NICM is a broad category that includes a wide spectrum of causes, which may include: bacterial, viral toxin mediated and immune mediated and "unexplained" when coronary disease has been excluded. The pathophysiology of NICM is not well understood but inflammatory responses with macrophage recruitment during remodeling have been described. On the other hand, an infectious trigger i.e. myocarditis may be the inciting event for the development of cardiomyopathy. A previous study b...

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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)