Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
- Conditions
- Systolic Heart FailureHeart Failure
- Registration Number
- NCT01932294
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Heart Failure Participants Deceased at 24 Months 6 month intervals after the baseline visit up to 24 months Death after the baseline visit up to 24 months
- Secondary Outcome Measures
Name Time Method Number of Participants With Known Ventricular Assist Device (VAD) Implantation 6 month intervals after the baseline visit up to 24 months Known VAD implantation after the baseline visit up to 24 months
Number of Participants With Known Heart Transplantation 6 month intervals after the baseline visit up to 24 months Heart transplantation after the baseline visit up to 24 months
Trial Locations
- Locations (11)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Cedars Sinai Medical Center
🇺🇸Beverly Hills, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Duke University
🇺🇸Durham, North Carolina, United States