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NCT04191681PHASE4Recruiting

Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study

The Cleveland Clinic

Start Date

11/8/2019

Completion Date

12/1/2022

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.

Detailed 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

Age Range: 18 years to No maximum

Inclusion Criteria: 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 Exclusion Criteria: 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.

Interventions

DRUG

Sacubitril-Valsartan

DRUG

Usual care (standard-of-care) arm

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Conditions

Stage D Heart Failure

Locations

Cleveland Clinic

Cleveland, Ohio 44195

United States