Immune System Suppression for Ventricular Arrhythmia

(IMMUNE VT Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Roderick Tung

Must not be taking: Corticosteroids

Disqualifiers: Pregnancy, HIV, Chronic infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants will be on either immunosuppressive drugs or standard treatment without immunosuppressants, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Prednisone for treating ventricular arrhythmia?

Research shows that immunosuppressive therapy, including drugs like Prednisone, can significantly reduce inflammation and effectively suppress arrhythmias in patients with chronic myocarditis, a condition that can lead to ventricular arrhythmias. ^{1 2 3 4 5}

Is immune system suppression treatment generally safe for humans?

Prednisone and similar drugs, used for immune system suppression, are generally safe but can have side effects like bradycardia (slow heart rate), especially at high doses. Common side effects include high blood sugar, high blood pressure, and bone thinning, but these are usually manageable. ^{1 2 3 6 7}

How does the drug Prednisone differ from other treatments for ventricular arrhythmia?

Prednisone is unique because it works by suppressing the immune system to reduce inflammation in the heart, which can help control ventricular arrhythmias linked to chronic myocarditis. This approach is different from standard treatments that typically focus on controlling heart rhythm directly with antiarrhythmic drugs or devices like defibrillators. ^{1 2 8 9 10}

Eligibility Criteria

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.

Inclusion Criteria

History of VA (documentation of Sustained VT last more than 30 seconds)

No evidence of obstructive coronary disease

Heart inflammation confirmed by PET scan

Exclusion Criteria

Life expectancy less than 24 months

Any patient with HIV, low white blood cells, and chronic infection (active fungal, TB, Valley fever)

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Baseline tests including physical exams, blood tests, genetic test, electrocardiography, and echocardiography are conducted

1 week

Treatment

Participants receive an 8-week medication regimen with either immunosuppressive drugs or standard GDMT without immunosuppressant medication

8 weeks

Regular visits for monitoring and evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of QRS duration, NYHA functional class, and adverse events

12 months

Treatment Details

Interventions

• Prednisone

Trial Overview 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.

Participant Groups

Group I: Immunosuppression Experimental Treatment 1 Intervention

Prednisone 40mg x 8weeks + GDMT

Group II: Standard of Care Active Control 1 Intervention

GDMT alone

Prednisone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Prednisone for:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Approved in European Union as Prednisone for:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Approved in Canada as Prednisone for:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Who Is Running the Clinical Trial?

Roderick Tung

Lead Sponsor

Trials

1

Recruited

40+

Findings from Research

In a study of 68 children with acute myocarditis lasting 3 months, those treated with prednisolone showed a significant improvement in heart function, as measured by ejection fraction, compared to the control group after one month (p = 0.029).

By the end of the follow-up period, more children in the prednisolone group had an ejection fraction greater than 60%, indicating a notable recovery from left ventricular failure (p = 0.049).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute viral myocarditis: role of immunosuppression: a prospective randomised study. Aziz, KU., Patel, N., Sadullah, T., et al.[2021]

In a study of 13 children with biopsy-proven myocarditis, steroid therapy (prednisone) led to significant clinical improvements, including normalization of ECG changes and heart function, with no significant side effects reported.

Repeat biopsies showed improvement in all patients, with six out of eight showing elimination of inflammatory infiltrate, suggesting that immunosuppressive therapy can effectively enhance recovery in pediatric myocarditis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunosuppressive therapy in the management of acute myocarditis in children: a clinical trial. Chan, KY., Iwahara, M., Benson, LN., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Immunosuppressive therapy for effective suppression of life threatening ventricular tachyarrhythmias in chronic myocarditis]. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Acute viral myocarditis: role of immunosuppression: a prospective randomised study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Bradycardia Associated with Prednisolone in Children with Severe Kawasaki Disease. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Immunosuppressive therapy in the management of acute myocarditis in children: a clinical trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Beta-blocker therapy in the Cardiac Arrhythmia Suppression Trial. CAST Investigators. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Dose-dependent bradycardia as a rare side effect of corticosteroids: a case report and review of the literature. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Corticosteroids in the management of sinoatrial block. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Immunosuppressive Therapy and Risk Stratification of Patients With Myocarditis Presenting With Ventricular Arrhythmias. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

Cardiac Arrhythmias in Autoimmune Diseases. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Lymphocytic myocarditis presenting as unexplained ventricular arrhythmias: diagnosis with endomyocardial biopsy and response to immunosuppression. [2021]