Electrogram-Guided Myocardial Advanced Phenotyping (The eMAP Trial)

Overview

Información sobre este estudio

Fluoroscopy guided EMB and EAM guided EMB on all patients meeting existing guidelines for biopsy.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Konstantinos Siontis, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20401444

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