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RECRUITING
NCT04191681
PHASE4

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2019-11-08

Completion Date

2022-12

Last Updated

2021-06-07

Healthy Volunteers

No

Interventions

DRUG

Sacubitril-Valsartan

Sacubitril-valsartan at low or equivalent dose to be initiated or added to patients randomized to this arm, and titrated up every 2-4 weeks, per standard practice guidelines and label recommendations per physician's discretion.

DRUG

Usual care (standard-of-care) arm

Other oral vasodilator therapy to be continued or initiated to patients randomized to this arm, and titrated up every 2-4 weeks, per standard practice guidelines and label recommendations per physician's discretion.

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States