NCT01932294

Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 171 (actual)
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Systolic Heart Failure

Timeline

• Start date: 2013-04-01
• Primary completion: 2017-01-20
• Completion: 2017-01-20
• First posted: 2013-08-30
• Last updated: 2018-12-06
• Results posted: 2018-12-06

Locations

11 sites across 1 country: United States