Electrogram-Guided Myocardial Advanced Phenotyping (The eMAP Trial)

Overview

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Suraj Kapa, M.D.

Open for enrollment

Contact information:

Tonya Sands

(507)538-5427

Sands.Tonya@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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