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Corticosteroid

Immune System Suppression for Ventricular Arrhythmia (IMMUNE VT Trial)

Phase 4
Waitlist Available
Research Sponsored by Roderick Tung
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
LV systolic function < 50%
No evidence of ischemic cardiomyopathy
Must not have
Hypothalamic-pituitary-adrenal axis suppression, Cushing's syndrome, active infection, glaucoma or any other pathology where corticosteroids are not recommended
Contraindications or intolerance of prednisone or any excipients in the formulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months (8 weeks and 6 months)
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial aims to study the benefit of using immunosuppressive therapy to treat a condition called ventricular tachycardia in individuals with non-ischemic cardiomyopathy. Participants will undergo

Who is the study for?
This trial is for individuals with unexplained heart function issues and irregular heartbeat due to conditions like Ventricular Arrhythmia, Myocarditis, or Cardiomyopathy. Participants must show inflammation in the heart via PET imaging and be able to undergo various baseline tests.
What is being tested?
The study is testing if Prednisone, an immunosuppressive drug at a dose of 40mg, can suppress rapid ventricle beating (VT), improve heart function, reduce hospital visits and avoid invasive procedures compared to standard treatment without immunosuppression over an 8-week period.
What are the potential side effects?
Prednisone may cause side effects such as increased risk of infection, changes in mood or behavior, elevated blood sugar levels especially in diabetics, bone weakening with long-term use, weight gain and fluid retention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart's pumping ability is below 50%.
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My heart does not have ischemic cardiomyopathy.
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I have heart failure but can still walk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have conditions like Cushing's syndrome or glaucoma where steroids are not advised.
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I cannot take prednisone or certain medication ingredients due to allergies or side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months (8 weeks and 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months (8 weeks and 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Burden of ventricular arrhythmias
Change in FDG (18F-fluorodeoxyglucose) uptake
Change in QRS duration
+1 more
Secondary study objectives
Cardiovascular hospitalization
NYHA functional class
Need for catheter ablation
+1 more
Other study objectives
Medication adverse events
System related adverse events

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ImmunosuppressionExperimental Treatment1 Intervention
Prednisone 40mg x 8weeks + GDMT
Group II: Standard of CareActive Control1 Intervention
GDMT alone

Find a Location

Who is running the clinical trial?

Roderick TungLead Sponsor
~27 spots leftby Oct 2026
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