Non-ischemic Cardiomyopathy Clinical Trial
Official title:
Electrogram-Guided Myocardial Advanced Phenotyping (The eMAP Trial)
Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.
Non-Ischemic Cardiomyopathy (NICM) is a common cause of heart failure (HF) and death. NICM is a heterogeneous entity, and specific etiologies are infrequently identified. In part due to limited disease characterization, specific treatments are lacking for most of the different underlying causes of NICM. Depending on the cohort, 30-70 percent of patients with new-onset NICM develop persistent systolic dysfunction despite guideline-directed medical therapy, and these patients have high rates of subsequent morbidity and resource utilization. Current guidelines support the use of endomyocardial biopsy (EMB) in patients with both new-onset and persistent cardiomyopathy. However, EMB is underutilized in these populations due to its low diagnostic yield. A combination of sampling error resulting from standard fluoroscopy-guided EMB in disease entities with patchy myocardial involvement and rudimentary tissue phenotyping of the specimens which are obtained contribute to this low diagnostic yield. In recent years, there has been increasing interest in the use of electro-anatomic mapping (EAM) to help identify areas of myocardium with discrete pathology based on abnormalities in intra-cardiac electrogram voltage and morphologies. Therefore, the primary objective of this protocol is to provide definitive evidence that EAM-guided biopsy leads to a superior diagnostic yield compared with conventional fluoroscopy-guided biopsy in patients with new-onset and persistent NICM. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Not yet recruiting |
NCT01447069 -
Use of Beta-agonists in Stable Severe Congestive Heart Failure
|
N/A | |
| Recruiting |
NCT05572957 -
LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB
|
N/A | |
| Recruiting |
NCT03830957 -
Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
|
N/A | |
| Suspended |
NCT03071653 -
Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study
|
Phase 2 | |
| Terminated |
NCT03925324 -
Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device
|
Phase 2 | |
| Completed |
NCT02657967 -
Development of an Evidenced-Based Tool for Prediction of Sudden Death in Patients With Non-Ischemic Cardiomyopathy
|
||
| Recruiting |
NCT05855135 -
Assessment of Combined CCM and ICD Device in HFrEF
|
N/A | |
| Completed |
NCT04325594 -
The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-ischemic Heart Failure
|
Phase 2 | |
| Active, not recruiting |
NCT01643330 -
A Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure
|
Phase 2 | |
| Terminated |
NCT01935622 -
Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy
|
Phase 2 | |
| Completed |
NCT03509441 -
Early MRI Detection of Myocardial Deterioration as a Preventive, Disease Staging, and Prognostic Biomarker in Insulin Resistance
|
||
| Completed |
NCT04607265 -
Sudden Death Stratification
|
||
| Withdrawn |
NCT01787851 -
Study of the Acute Effects of Triheptanoin in Heart Failure
|
Phase 1/Phase 2 | |
| Terminated |
NCT01966887 -
AAV1-CMV-Serca2a GENe Therapy Trial in Heart Failure
|
Phase 2 | |
| Recruiting |
NCT06243653 -
Relationship Between Coronary Microvascular Dysfunction and Improvement of Left Ventricular Systolic Function in Patients With Heart Failure With Reduced Ejection Fraction Caused by Non-ischemic Etiology
|
||
| Recruiting |
NCT04265040 -
DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies
|
||
| Terminated |
NCT02346422 -
A Phase 1/2 Study of High-dose Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure
|
Phase 1/Phase 2 |