Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support

Completed

• Conditions: Systolic Heart Failure; Heart Failure

• Registration Number: NCT01932294
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Status Verified: 2017-01
• Primary Completion: 2017-01-20
• Study Completion: 2017-01-20
• Results First Submitted: 2018-09-20
• Results First Submitted QC: 2018-11-08
• Last Update Submitted: 2018-11-08
• Results First Posted: 2018-12-06
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

Not provided

Exclusion Criteria

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

Cedars Sinai Medical Center; 🇺🇸 Beverly Hills, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

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