N/A
Completed N=171
Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
Heart Failure · Systolic Heart Failure
Source: ClinicalTrials.gov NCT01932294 ↗
Enrolled (actual)
171
Serious AEs
54.4%
Results posted
Dec 2018
Primary outcomePrimary: Number of Heart Failure Participants Deceased at 24 Months — 43 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Heart Failure Participants Deceased at 24 Months |
43 | — |
| SECONDARY Number of Participants With Known Ventricular Assist Device (VAD) Implantation |
20 | — |
| SECONDARY Number of Participants With Known Heart Transplantation |
16 | — |
Eligibility Criteria
INCLUSION CRITERIA
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
OR
- Peak oxygen uptake (VO2) 1.08 on cardiopulmonary exercise testing.
- 6-minute walk distance 1000 (NT-proBNP > 4000 pg/ml) as outpatient or at hospital discharge.
OR
Seattle Heart Failure Model Score > 1.5.
EXCLUSION CRITERIA
- Age >80 years or 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.
Data sourced from ClinicalTrials.gov (NCT01932294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.