Electrogram-Guided Myocardial Advanced Phenotyping (The eMAP Trial)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-003245
NCT ID: NCT03293381
Sponsor Protocol Number: 17-003245
About this study
Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years
- 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.
- 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.
- Willingness to provide informed consent
Exclusion Criteria:
- Prior diagnosis of HF or documented LVEF < 45% more than 6 months prior to enrollment.
- 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.
- Ongoing hemodynamically significant arrhythmias deemed to be an independent cause of HF decompensation
- Constrictive pericarditis or tamponade
- Complex congenital heart disease
- History of malignancy with treatment by anthracyclines or other known cardiotoxic chemotherapeutic agents
- More than mild aortic or mitral stenosis
- Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation
- Primary hypertrophic cardiomyopathy
- Untreated thyroid disease
- Severe nutritional deficiency
- Severe uncontrolled hypertension
- Sepsis, active infection (excluding cystitis) or other comorbidity driving the HF decompensation
- History of cardiac transplantation
- 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
- Inability to comply with planned study procedures
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available