Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635863
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Comparing Immune System Suppression to Medication for Unexplained Heart Function and Irregular Heartbeat
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Immunosuppression Versus Medical Therapy for UN-explained Low Ejection Fraction and VT
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMMUNE VT
Brief 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
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
Detailed Description:
Ventricular arrhythmia VT is a well-established consequence in patients with non-ischemic cardiomyopathy NICM NICM is a broad category that includes a wide spectrum of causes which may include bacterial viral toxin mediated and immune mediated and unexplained when coronary disease has been excluded The pathophysiology of NICM is not well understood but inflammatory responses with macrophage recruitment during remodeling have been described On the other hand an infectious trigger ie myocarditis may be the inciting event for the development of cardiomyopathy A previous study by Tung et al showed that nearly 50 of patients with unexplained cardiomyopathy and ventricular arrhythmias presented ongoing focal myocardial inflammation on PET To date targeting inflammation as a substrate in order to reduce burden of ventricular tachycardia has not been investigated in randomized prospective fashion
The TIMIC trial was one of the few randomized studies to examine long-term benefit of immunosuppressive therapies in patients with virus-negative NICM A moderate improvement in Left Ventricular Ejection Fraction LVEF over 6 months after initiation of immunosuppressive therapy was demonstrated in this study but current guidelines do not routinely recommend anti-inflammatory therapies for NICM While considered to be gold standard endomyocardial biopsy can often times be incorrect due to sampling error and typically is not performed multiple times in patient with chronic non-ischemic cardiomyopathy Fasting Fluorodeoxyglucose FDG-positron emission tomography PET is an emerging imaging modality to identify and monitor abnormal metabolic patterns of the myocardium By exploiting the metabolic demand of inflammatory tissue with macrophage recruitment PET imaging is emerging as the preferred modality to diagnose and measure response to therapy for patients with myocarditis and sarcoidosis A recent study by Kandolin et al in Finland showed that the incidence of cardiac sarcoidosis has increased by 20-fold over the past two decades
FDG-PET may reveal inflammation as a central pathophysiologic mechanism in a significant proportion of patients with unexplained cardiomyopathy and VT Potential innovative insights from the trial will be to identify the underlying pathogenesis of idiopathic cardiomyopathy and assess whether immunosuppression changes the clinical course of patients with identified arrhythmogenic cardiomyopathy Aside from guideline-direct medical therapy GDMT antiarrhythmic agents and catheter ablation there are no disease-specific therapies for patients with VT and NICM Prospective studies that evaluate the incidence of occult inflammation and clinical response to anti-inflammatory and immunosuppressive therapy have not been performed to date and are warranted for the emerging NICM population referred for advanced heart failure and arrhythmia management
The TIMIC trial was one of the few randomized studies to examine long-term benefit of immunosuppressive therapies in patients with virus-negative NICM A moderate improvement in Left Ventricular Ejection Fraction LVEF over 6 months after initiation of immunosuppressive therapy was demonstrated in this study but current guidelines do not routinely recommend anti-inflammatory therapies for NICM While considered to be gold standard endomyocardial biopsy can often times be incorrect due to sampling error and typically is not performed multiple times in patient with chronic non-ischemic cardiomyopathy Fasting Fluorodeoxyglucose FDG-positron emission tomography PET is an emerging imaging modality to identify and monitor abnormal metabolic patterns of the myocardium By exploiting the metabolic demand of inflammatory tissue with macrophage recruitment PET imaging is emerging as the preferred modality to diagnose and measure response to therapy for patients with myocarditis and sarcoidosis A recent study by Kandolin et al in Finland showed that the incidence of cardiac sarcoidosis has increased by 20-fold over the past two decades
FDG-PET may reveal inflammation as a central pathophysiologic mechanism in a significant proportion of patients with unexplained cardiomyopathy and VT Potential innovative insights from the trial will be to identify the underlying pathogenesis of idiopathic cardiomyopathy and assess whether immunosuppression changes the clinical course of patients with identified arrhythmogenic cardiomyopathy Aside from guideline-direct medical therapy GDMT antiarrhythmic agents and catheter ablation there are no disease-specific therapies for patients with VT and NICM Prospective studies that evaluate the incidence of occult inflammation and clinical response to anti-inflammatory and immunosuppressive therapy have not been performed to date and are warranted for the emerging NICM population referred for advanced heart failure and arrhythmia management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None