Electrogram-Guided Myocardial Advanced Phenotyping (The eMAP Trial)

Overview

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Suraj Kapa, M.D.

Open for enrollment

Contact information:

Hannah Frost CCRP

(507)293-2762

Frost.Hannah@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20401444

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