Heart Failure Clinical Trial
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
Summary
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.
Full 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 Criteria
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:
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.
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