Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support (Medamacs)
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|ClinicalTrials.gov Identifier: NCT01932294|
Recruitment Status : Completed
First Posted : August 30, 2013
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
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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 :||171 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support|
|Actual 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.
- Number of Heart Failure Participants Deceased at 24 Months [ Time Frame: 6 month intervals after the baseline visit up to 24 months ]Death after the baseline visit up to 24 months
- Number of Participants With Known Ventricular Assist Device (VAD) Implantation [ Time Frame: 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 [ Time Frame: 6 month intervals after the baseline visit up to 24 months ]Heart transplantation after the baseline visit up to 24 months
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Patients with Advanced Heart Failure
- Age 18-80 years
- New York Heart Association class III-IV heart failure for 45 of the last 60 days
- Left ventricular ejection fraction ≤ 35%
- Heart failure diagnosis or typical symptoms for 12 months
- Use of evidence based oral medications (beta-blockers, ACE-inhibitors/ARBs, aldosterone antagonist) for at least 3 months prior to enrollment or documented medication contraindication or intolerance.
- Hospitalization for heart failure within the previous 12 months (other than for elective procedure)
- Informed consent given
In Addition, they must have at least one of the following:
An additional unplanned hospitalization during the previous 12 months for a total of at least 2 inpatient hospitalizations lasting >24 hours with heart failure as the primary or secondary diagnosis within the previous 12 months
- Peak oxygen uptake (VO2) <55% of age- and sex-predicted (using Wasserman equation) OR a peak VO2 ≤16 ml/kg/min for men and ≤14 ml/kg/min for women in a test with an RER >1.08 on cardiopulmonary exercise testing.
- 6-minute walk distance <300 meters without non-cardiac limitation.
- Serum BNP > 1000 (NT-proBNP > 4000 pg/ml) as outpatient or at hospital discharge.
Seattle Heart Failure Model Score > 1.5.
- Age >80 years or <18 years
- Non-cardiac diagnosis anticipated to limit 2-year survival (≥30-50% mortality within 2 years from non-cardiac diagnosis)
- Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival
- QRS > 120msec and planned biventricular pacemaker implant or biventricular pacemaker implantation within past 90 days
- Current home intravenous inotrope therapy
- Chronic hemodialysis or peritoneal dialysis
- Scheduled for non-ventricular assist device cardiac surgery on current hospital admission
- Obvious anatomical or other major contra-indication to any cardiac surgery in the future (e.g. previous pneumonectomy, advanced connective tissue disease)
- Actively listed for heart transplant as UNOS Status 1 or 2
- History of cardiac amyloidosis
- Dominant lesion of at least moderate aortic or mitral stenosis or congenital structural heart defect.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
Documents provided by National Heart, Lung, and Blood Institute (NHLBI):
|Responsible Party:||National Heart, Lung, and Blood Institute (NHLBI)|
|Other Study ID Numbers:||
|First Posted:||August 30, 2013 Key Record Dates|
|Results First Posted:||December 6, 2018|
|Last Update Posted:||December 6, 2018|
|Last Verified:||January 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Individual participant data (IPD) is not available. De-identified datasets may be available upon approval.|
Advanced Heart Failure
Refractory Heart Failure
Mechanical Circulatory Support Device
Ventricular Assist Device
Heart Failure, Systolic