Sacubitril/Valsartan in Left Ventricular Assist Device Recipients
Sacubitril/Valsartan in Left Ventricular Assist Device Recipients
The primary objective of this study is to assess the safety and tolerability of
 sacubitril/valsartan compared with standard of care used for treating BP in patients that
 have been implanted with the Heart Mate 3 LVAD (events of special interest - all cause death,
 right ventricular failure, bleeding events, deterioration in renal function, hyperkalemia,
 symptomatic hypotension).
Inclusion Criteria:

 1. Written informed consent must be obtained before any assessment is performed.

 2. ≥18 years of age, male or female

 3. Recently implanted HeartMate 3 LVAD recipients, in stable condition and deemed ready
 for discharge or chronic, stable, ambulatory HeartMate 3 LVAD carriers implanted
 within 1 year prior to enrolment

 1. Current acute decompensated HF (including right ventricular failure) requiring therapy
 with intravenous diuretics or vasodilators and/or inotropic drugs within the past 48 hours
 2. History of hypersensitivity to sacubitril/valsartan or to drugs of similar chemical
 classes, patients with a known history of angioedema 3. Patients with mean blood pressure
 ≤75 mmHg (systolic blood pressure i.e. Doppler opening blood pressure ≤90 mmHg in those
 pulsatile and measured by Doppler method) or symptomatic hypotension 4. eGFR < 30
 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at
 Visit 1 5. Patients with serum potassium >5.4 mmol/L (mEq/L) at Visit 1 6. Hemodynamically
 unstable patients or those with ongoing MCS other than LVAD or those with planned
 biventricular support 7. Hemodynamically significant aortic insufficiency in the opinion of
 the investigator 8. Irreversible end-organ dysfunction 9. Previous sacubitril/valsartan use
 while on LVAD support 10. Acute coronary syndrome, stroke, transient ischemic attack,
 cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or
 carotid angioplasty within 30 days prior to enrolment 11. Life-threatening or uncontrolled
 dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial
 fibrillation or flutter with a resting ventricular rate >110 bpm at enrolment 12. Any
 surgical or medical condition, which in the opinion of the Investigator, may place the
 patient at higher risk from his/her participation in the study, or is likely to prevent the
 patient from complying with the requirements of the study or completing the study 13.
 Active infection with hemodynamic compromise 14. hemoglobin (Hgb) <8 g/dl 15. body mass
 index (BMI) > 45 kg/m2 16. Congenital heart disease 17. Coronary or carotid artery disease
 or valvular heart disease likely to require surgical or percutaneous intervention within
 the 6 months after enrolment 18. Evidence of hepatic disease as determined by any one of
 the following: SGOT (AST) or SGPT (ALT) values exceeding 3x ULN, bilirubin >1.5 mg/dl at
 Visit 1 19. Pregnant or nursing (lactating) women and women of child-bearing potential
 unless they are using highly effective methods of contraception