Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support (Medamacs)
|ClinicalTrials.gov Identifier: NCT01932294|
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : January 26, 2017
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.
|Condition or disease|
|Heart Failure Systolic Heart Failure|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||161 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||January 20, 2017|
|Actual Study Completion Date :||January 20, 2017|
All participants who have met the inclusion criteria.
- Survival rate of heart failure patients who were treated medically without a Ventricular Assist Device [ Time Frame: Measured through 24 months ]Following 2 baseline visits (3 to 6 weeks apart), participants will be followed at 6 month intervals for 24 months.
- Events [ Time Frame: Measured through 24 months. ]Events (hospitalization, heart transplantation, VAD, death, infection, neurologic, bleeding) will be collected at baseline and at 6 month intervals for 24 months.
- Quality of Life [ Time Frame: Measured through 24 months. ]Quality of life measures will be collected at baseline and at 6 month intervals for 24 months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932294
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Cedars Sinai Medical Center|
|Beverly Hills, California, United States, 90211|
|United States, Colorado|
|University of Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||James K Kirklin, MD||INTERMACS Principal Investigator|