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LVAD Body Compositon Study


Title How Does Body Composition Change after Placement of a Left Ventricular Assist Device in Advanced Systolic Heart Failure?
Therapeutic Area Cardiac Failure, Cardiomyopathy, Cardiovascular Disease, Heart Failure
Principal Investigator Amanda Vest, MD
Min Age 19 Years
Gender All
Contact Amanda Vest, MD
617 636 6049 / avest@tuftsmedicalcenter.org

Overview

Many patients with advanced heart failure describe loss of muscle mass and strength in their arms and legs. This process is known as ‘sarcopenia’ and has not been well studied in heart failure. In particular it is unknown whether the sarcopenia process can reverse after a heart failure patient receives a left ventricular assist device (LVAD, a surgically implanted heart pumpt). Therefore we are partnering with experts in nutrition and body composition at Tufts University to study changes in muscle mass, physical activity, food intake and metabolism in patients receiving an LVAD. Muscle mass is measured by two methods in the study, to help us determine which is the most accurate in heart failure patients: a dual-energy x-ray absorptiometry (DXA) scan and a non-radioactive isotope dilution technique. There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation.

Study Details

Inclusion Criteria

  • Adult patients 18+ years of age, with advanced systolic heart failure and undergoing evaluation for LVAD implantation

Exclusion Criteria

  • Patients who are on temporary mechanical support prior to LVAD implantation will be excluded from enrollment at that time due to clinical instability; however they will still be eligible to enroll and participate in the baseline study during the post-LVAD 21 day window, if clinically stable to do so.

Study Requirements

There are 3 study visits which each take a maximum of 4 hours, performed around the time of LVAD implant (30 days before to 21 days after), and at 3 months and 6 months after LVAD implantation. During these visits patients will be asked to do the following:
  • short physical assessment
  • 3 questionnaires
  • 2 blood draws (one at the start of the visit and one 4 hours later)
  • full body xray (DXA scan)
  • Metabolic cart for measurement of resting energy expenditure