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

Launched by RODERICK TUNG · Oct 8, 2024

Keywords

ClinConnect Summary

This trial is studying whether adding a short course of prednisone (an anti-inflammatory medicine) to standard heart care helps people with a specific type of non-ischemic cardiomyopathy who also have inflammation in the heart and a history of dangerous heart rhythms (ventricular tachycardia). It is a randomized study, meaning eligible participants are randomly assigned to either immunosuppression plus usual care or usual care alone. The main goal is to see if this approach reduces the ongoing ventricular tachycardia over 12 months and whether it improves heart function and reduces the need for further procedures.

People who might be eligible are adults 18 or older with a left heart pumping function below normal (LV ejection fraction under 50%), symptoms that fit NYHA class II–IV, and a history of sustained ventricular arrhythmias. They must have evidence of heart inflammation on PET imaging and currently be on guideline-based heart medications, with ischemic heart disease ruled out. The study involves an 8-week prednisone course (40 mg daily) plus standard care or standard care alone, with follow-up tests over 12 months. Possible side effects from steroids and other study-adverse events will be monitored. The study is planned to enroll about 40 people at Banner – University Medical Center in Phoenix, and results may help clarify whether adding anti-inflammatory therapy can change the course of this condition.

Gender

ALL

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)