Overview
The purpose of the study is to evaluate how well tolerated and effective an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) is in patients with contemporary durable continuous flow left ventricular assist device (CF-LVAD) implantation compared to usual care oral vasodilator therapy.
Description
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.
Eligibility
Inclusion Criteria:
- Adults (age ≥ 18 years)
- Durable CF-LVAD for any indication
- NYHA II to IV classification
- LVEF < 40%
- Written informed consent
Exclusion Criteria:
- Inability to comply with the conditions of the protocol
- Any patient with durable CF-LVAD who has any one of the following:
- 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,
- 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.