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

Safety and Efficacy of Angiotensin Receptor-neprilysin Inhibitor After Left Ventricular Assist Device ImplanT (SEAL-IT) Study

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• Sacubitril-Valsartan (drug)
• Usual care (standard-of-care) arm (drug)

Sponsor: The Cleveland Clinic · Participants: 50 · Started: Nov 8, 2019

Contact the study team

• Jerry D Estep, MD · Phone: 216-444-7646

Official record on ClinicalTrials.gov — NCT04191681

Locations in the U.S.

Conditions

• Heart Failure

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.