Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
Condition: Heart Failure; Systolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Systolic
Study type: Observational [Patient Registry]

Summary: 
      Medamacs is a prospective, observational study of ambulatory patients with advanced heart
      failure. The study enrolls patients who have not yet received a Left Ventricular Assist
      Device (LVAD) but who receive their care at a hospital with a Joint Commission certified
      mechanical circulatory support program.

      Medamacs is funded through the Interagency for Mechanically Assisted Circulatory Support
      (INTERMACS) NHLBI Contract.
    

Detailed description: 
      Participants between 18 and 80 years old with low ejection fraction history and
      hospitalization for heart failure within the past year will be screened for the study. All
      subjects who have been admitted to the heart failure service will be screened and recruited,
      either as an inpatient or during their first outpatient follow-up appointment by the
      investigator and research staff caring for patients in the advanced heart failure program.

      Eligibility for enrollment will be based only upon information that is clinically available
      at the time of screening. The history of prior hospitalizations will be available from
      clinical records.

      Routine evaluation and triage of ambulatory patients with advanced heart disease includes
      echocardiography and functional assessment with peak oxygen consumption and frequently 6
      minute walk distance. The elements of information required for estimation of the Seattle
      Heart Failure Risk score will be gleaned from laboratory data, or imputed as described in the
      Seattle score literature. The research coordinator will enter this data onto a currently
      available website for calculation of the Seattle score.

      Eligibility will be determined by the inclusion and exclusion criteria and the study research
      team will approach individual subjects who are potential candidates for participation once
      the subject's primary physician has given permission to approach. Only persons with a
      scientific or ethical reason will be excluded. Incarcerated prisoners have been excluded by
      this protocol.

      Participants will be followed every 6 months for 24 months after two baseline visits. The 6
      month and 18 month follow ups consist of telephone interviews. Follow ups at 12 months and 24
      months consists of routine clinical visits.

      Approximately 350 patients from 12 centers in the United States will be enrolled over a 12
      month period.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be screened for this study if they are between 18 and 80 years old with
        low ejection fraction history and hospitalization for heart failure within the past year.
        All subjects who have been admitted to the heart failure service will be screened and
        recruited for study participation, either as an inpatient or during their first outpatient
        follow-up appointment by the investigator and research staff caring for patients in the
        advanced heart failure program of the enrolling center.
      
Keywords: Advanced Heart Failure; Refractory Heart Failure; Mechanical Circulatory Support Device; Ventricular Assist Device; Medamacs