Non-ischemic Cardiomyopathy Clinical Trial
— eMAPOfficial title:
Electrogram-Guided Myocardial Advanced Phenotyping (The eMAP Trial)
Verified date | February 2024 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | November 30, 2025 |
Est. primary completion date | November 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Age = 18 years 2. New onset NICM as defined by the presence of left ventricular dysfunction (LVEF < 45% by echocardiography and/or MRI), with symptoms or signs of HF (dyspnea, orthopnea, edema, ascites, rales or pulmonary vascular congestion on chest radiography) of less than 3 months in duration. 3. Persistent recent onset NICM as defined by the LVEF and signs/symptoms in #2 above with persistence of the LVEF < 45% despite evidence-based treatment for HF with reduced LVEF for 2 to 6 months. 4. Willingness to provide informed consent - Exclusion Criteria: 1. Prior diagnosis of HF or documented LVEF < 45% more than 6 months prior to enrollment. 2. Coronary artery disease, either by history or as determined by coronary angiography demonstrating hemodynamically significant lesions deemed sufficient to potentially contribute to left ventricular dysfunction. 3. Ongoing hemodynamically significant arrhythmias deemed to be an independent cause of HF decompensation 4. Constrictive pericarditis or tamponade 5. Complex congenital heart disease 6. History of malignancy with treatment by anthracyclines or other known cardiotoxic chemotherapeutic agents 7. More than mild aortic or mitral stenosis 8. Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation 9. Primary hypertrophic cardiomyopathy 10. Untreated thyroid disease 11. Severe nutritional deficiency 12. Severe uncontrolled hypertension 13. Sepsis, active infection (excluding cystitis) or other comorbidity driving the HF decompensation 14. History of cardiac transplantation 15. Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR > 1.5 in the absence of anticoagulation treatment 16. Inability to comply with planned study procedures - |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Mayo clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Biosense Webster, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy. | Additional biopsies | November 2018 |
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 |