Comparing Immune System Suppression to Medication for Unexplained Heart Function and Irregular He… (NCT06635863) | Clinical Trial Compass
By InvitationPhase 4
Comparing Immune System Suppression to Medication for Unexplained Heart Function and Irregular Heartbeat
United States40 participantsStarted 2024-11-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Burden of ventricular arrhythmias
Timeframe: 12 months (8 weeks and 6 months)
2
Change in left ventricular ejection fraction (LVEF)