Tests sacubitril-valsartan in people with advanced heart failure who have a heart pump
Tests sacubitril-valsartan against usual care in adults with advanced heart failure and a heart pump.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
Key facts
- Where
- Cleveland, United StatesSee the site
- Phase
- Phase 4
Where in United States
- Cleveland ClinicCleveland, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Cleveland Clinic
- Trial code
- NCT04191681
- Record updated
- 7 June 2021
- Original description
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.Read full original descriptionShow less
Safety and Efficacy of Angiotensin Receptor-neprilysin Inhibitor After Left Ventricular Assist Device ImplanT (SEAL-IT) Study
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.
Inclusion: Adults (age ≥ 18 years); Durable CF-LVAD for any indication; NYHA II to IV classification; LVEF < 40%; Written informed consent.
Exclusion: Inability to comply with the conditions of the protocol; Any patient with durable CF-LVAD who has any one of the following:; symptomatic hypotension or MAP < 60 mm Hg at randomization,; eGFR < 30 mL/min/1.73 m2 at randomization,; potassium > 5.4 mM at randomization,; history of angioedema at randomization,; history of unacceptable side effects with ACE inhibitor, ARB, or sacubitril-valsartan therapy at randomization,; use of vasoactive agents (e.g., dobutamine, dopamine, epinephrine, norepinephrine, phenylephrine, vasopressin, nitroglycerin, nitroprusside, epoprostenol) or parenteral diuretics in 24 hours preceding randomization.