The aim of this pilot study is to prospectively determine the short-term (at 3 months) and long-term (at 6 and 12 months) safety and efficacy of an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) in patients with contemporary durable continuous flow left ventricular assist device (CF-LVAD) implantation compared to standard-of-care (usual care) oral vasodilator therapy.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Adults (age ≥ 18 years)
2. Durable CF-LVAD for any indication
3. NYHA II to IV classification
4. LVEF \< 40%
5. Written informed consent
You may not be if
1. Inability to comply with the conditions of the protocol
2. Any patient with durable CF-LVAD who has any one of the following:
i. symptomatic hypotension or MAP \< 60 mm Hg at randomization,
ii. eGFR \< 30 mL/min/1.73 m2 at randomization,
iii. potassium \> 5.4 mM at randomization,
iv. history of angioedema at randomization,
v. history of unacceptable side effects with ACE inhibitor, ARB, or sacubitril-valsartan therapy at randomization,
vi. use of vasoactive agents (e.g., dobutamine, dopamine, epinephrine, norepinephrine, phenylephrine, vasopressin, nitroglycerin, nitroprusside, epoprostenol) or parenteral diuretics in 24 hours preceding randomization.
