Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support

Completed

Conditions studied: Heart Failure, Systolic Heart Failure

In brief

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.

Key facts

Study ID

NCT01932294

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

171

Starts

2013-04-01

Expected to finish

2017-01-20

Last updated by the study team

2018-12-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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