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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the immune-suppressing drug prednisone can aid individuals with ventricular tachycardia (VT), a condition where the heart beats too fast. The aim is to determine if prednisone can reduce VT episodes and enhance heart function without requiring hospital visits or surgeries. Participants will receive either prednisone with their usual heart medications or just the usual medications. Those who have experienced VT episodes lasting over 30 seconds, have heart inflammation visible on a PET scan, and do not have coronary artery disease may be suitable for this study. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

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 is the safety track record for these treatments?

Research has shown that prednisone, a drug often used to suppress the immune system, has mixed safety results. Some studies indicate it can be safely used in people who have had a heart attack. However, reports highlight increased risks with higher doses. For instance, taking more than 25 mg of prednisone daily can raise the risk of serious heart problems from 1.4% to 8.9%. Other studies suggest a possible connection between prednisone and certain heart issues, such as a tear in the heart wall, especially soon after a heart attack.

These findings suggest that while prednisone is often safe, it can have serious side effects, particularly at higher doses or in people with existing heart conditions. Participants should discuss these risks with their doctors before joining the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for ventricular arrhythmia focus on managing symptoms with medications like beta-blockers or antiarrhythmics, which help to stabilize heart rhythms. But prednisone, an anti-inflammatory corticosteroid, is being explored for its unique approach of immune system suppression. Researchers are excited because prednisone targets inflammation, which could be an underlying factor in some arrhythmias. This means it might offer benefits beyond just controlling symptoms, potentially addressing a root cause of the condition. If successful, this could provide a new therapeutic angle for patients who don't respond well to existing treatments.

What evidence suggests that immunosuppressive therapy might be an effective treatment for ventricular tachycardia?

This trial will compare the effects of standard care with an immunosuppression approach using Prednisone. Research has shown that Prednisone, a type of medication, can help manage irregular heartbeats by reducing inflammation. Studies suggest that these medications might work best if used early, as they can control inflammation and prevent further heart damage. In cases where the heart is inflamed, such as in cardiac sarcoidosis, high doses of similar treatments have effectively reduced dangerous heart rhythms. However, results are mixed because some research indicates that these medications might increase the risk of irregular heartbeats in certain situations. Overall, Prednisone might help by targeting heart inflammation, which is linked to irregular heartbeats. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6932647/

Effect of Corticosteroid Therapy on Ventricular Arrhythmias in ... Conclusions: Corticosteroid therapy may be effective for ventricular arrhythmias in the early stage, but less effective in the late stage. Ann Noninvasive ...

2. academic.oup.com academic.oup.com/ehjopen/article/7951279

Corticosteroid therapy and long-term outcomes in patients ... The administration of corticosteroids before the onset of LV dysfunction may control inflammation, prevent the development of LV dysfunction, ...

3. ahajournals.org ahajournals.org/doi/10.1161/circ.146.suppl_1.12678

Abstract 12678: Steroids versus Steroid-Sparing Agents in ... Patients in the SSA group were 77% less likely to develop heart failure with reduced ejection fraction (RR 0.23, p=0.0001), 72% less likely to ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214027120301445

High-dose intravenous glucocorticoids are effective in the ... In our case series, high-dose intravenous (IV) glucocorticoids were an effective treatment for malignant ventricular arrhythmias in cardiac sarcoidosis patients ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/jce.14689

Treatment with corticosteroids is associated with an ... Treatment with corticosteroids is associated with an increase in ventricular arrhythmia burden in patients with clinically manifest cardiac sarcoidosis.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10787466/

Adverse effects of corticosteroids on the cardiovascular ... Data sources: Case reports and studies demonstrating adverse effects of glucocorticoid therapy on the cardiovascular system were examined from a MEDLINE search.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002962924011005

Steroids and myocardial infarction: Investigating safety and ... In conclusion, using steroids is safe in post-MI patients with no significant increase in short-term mortality risk.

8. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000549

2017 AHA/ACC/HRS Guideline for Management of ... In the same population, nonsustained ventricular tachycardia (NSVT) was independently associated with increased risk of death and other ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/202020s012lbl.pdf

RAYOS (prednisone) - accessdata.fda.gov Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent ...

10. connect.mayoclinic.org connect.mayoclinic.org/discussion/risk-of-cardiovascular-disease-on-prednisone/

Risk of cardiovascular disease while on Prednisone. Risk for serious CV disorders for people taking more than 25 mg prednisone went up over sixfold, from 1.4% to 8.9%. A doubling of risk for ...