Immune System Suppression for Ventricular Arrhythmia
(IMMUNE VT Trial)
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Testing
Baseline tests including physical exams, blood tests, genetic test, electrocardiography, and echocardiography are conducted
Treatment
Participants receive an 8-week medication regimen with either immunosuppressive drugs or standard GDMT without immunosuppressant medication
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of QRS duration, NYHA functional class, and adverse events
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?
2
Treatment groups
Experimental Treatment
Active Control
Prednisone 40mg x 8weeks + GDMT
GDMT alone
Prednisone is already approved in United States, European Union, Canada for the following indications:
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
- Allergic reactions
- Asthma
- Blood disorders
- Cancer
- Eye problems
- Immune system disorders
- Inflammatory conditions
- Multiple sclerosis
- Organ transplantation
- Rheumatoid arthritis
- Skin conditions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roderick Tung
Lead Sponsor
Published Research Related to This Trial
Citations
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 ...
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, ...
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 ...
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 ...
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.
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.
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.
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 ...
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 ...
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