The Medical Arm of Mechanical Circulatory Support (MedaMACS) Study

Study ID
STU 112012-089

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Lynn Fernandez
214-645-8040
lynn.fernandez@utsouthwestern.edu

Principal Investigator
Jennifer Thibodeau

Summary

The MedaMaCS Pilot Study is a prospective, observational study of ambulatory patients with advanced heart failure. The study will enroll patients who have not yet received an LVaD but who receive their care at a hospital with a JCaHo-certified mechanical circulatory support program. There is an anticipated enrollment of 350 total patients from 12 uS centers over a 12 month period and we plan to enroll 30 subjects. The subjects will be followed for 24 months.

Participant Eligibility

1.) Age 18-80 years
2.) NYHA class III-IV heart failure for 45 days of the last 60 days
3.) Left ventricular ejection fraction <= 35%
4.) Heart failure diagnosis or typical symptoms for 12 months
5.) 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.
6.) Hospitalization for heart failure within the previous 12 months (other than for elective procedure)
7.) Informed consent given

In addition, they must have at least one of the following:

A. 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

B.
1) 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.
2) 6-minute walk distance <300 meters without non-cardiac limitation.
3) Serum BNP > 1000 (NT-proBNP > 4000 pg/ml) as outpatient or at hospital discharge.

OR

C. Seattle Heart Failure Model Score > 1.5.

Available information will be obtained on all of these inclusion criteria for comparison regardless of which meets eligibility.