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Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
Sponsor: The Cleveland Clinic
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
Conditions
Interventions
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.
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