Loading clinical trials...

Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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

NCT04191681•The Cleveland Clinic

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Key Dates

Start Date

November 8, 2019

Primary Completion Date

March 1, 2022

Completion Date

December 1, 2022

Last Updated

June 7, 2021

Enrollment

ESTIMATED participants

Conditions

Stage D Heart Failure

Interventions

Sacubitril-Valsartan

DRUG

Usual care (standard-of-care) arm

DRUG

Contacts

Jerry D Estep, MD

CONTACT

216-444-7646 estepj@ccf.org