Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
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.
⁃ 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) \<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.
⁃ OR
⁃ Seattle Heart Failure Model Score \> 1.5.