NCT06635863

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

Enrolling by Invitation
PHASE4Ages 18+InterventionalTreatment
Roderick Tung
~40 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Prednisone 40mg

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Burden of ventricular arrhythmias
Measured over 12 months (8 weeks and 6 months)
+3 more outcomes measured
Ventricular Arrythmia
Non-ischemic Cardiomyopathy
Arrhythmogenic Inflammatory Cardiomyopathy
1 sites across 1 states
Arizona1

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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)
  • Burden of ventricular arrhythmias12 months (8 weeks and 6 months)

    Documented sustained monomorphic ventricular tachycardia \>30 seconds or any appropriate defibrillator therapy (shock or antitachycardia pacing).

  • Change in left ventricular ejection fraction (LVEF)12 months (8 weeks and 6 months)

    Left ventricular ejection fraction measured with Simpson method with echocardiography.

  • Change in QRS duration12 months (8 weeks and 6 months)

    QRS duration (milliseconds) measured with a 12-lead ECG.

  • Change in FDG (18F-fluorodeoxyglucose) uptake12 months

    Change in FDG uptake compared to initial uptake assessed with 18F-fluorodeoxyglucose PET (FDG-PET). Myocardial FDG uptake will be reported as non, focal or diffuse and/or isolated with focal pattern.