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.

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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.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

50

Study ID:

NCT04191681

Recruitment Status:

Recruiting

Sponsor:

The Cleveland Clinic

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There is 1 Location for this study

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Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Jerry Estep, M. D.
Contact
216-444-7646
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

50

Study ID:

NCT04191681

Recruitment Status:

Recruiting

Sponsor:


The Cleveland Clinic

How clear is this clinincal trial information?

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