Safety and Efficacy of Angiotensin Receptor-neprilysin Inhibitor After Left Ventricular Assist Device ImplanT (SEAL-IT) Study
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.
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 range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 s…
Interventions
- DrugSacubitril-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.
- DrugUsual 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.
Location
- Cleveland ClinicCleveland, Ohio