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

Recruiting now · Phase 4

Conditions studied: Stage D Heart Failure

In brief

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.

Key facts

Study ID

NCT04191681

Run by

The Cleveland Clinic

People needed

50

Starts

2019-11-08

Expected to finish

2022-12-01

Last updated by the study team

2021-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (age ≥ 18 years)
• Durable CF-LVAD for any indication
• NYHA II to IV classification
• LVEF < 40%
• Written informed consent

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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