Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
Recruiting · NCT04191681 · Interventional (participants receive a specific treatment) · Lead sponsor: The Cleveland Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Sacubitril-ValsartanUsual care (standard-of-care) arm
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Adults (age ≥ 18 years)
- Durable CF-LVAD for any indication
- NYHA II to IV classification
- LVEF \< 40%
- Written informed consent
Exclusion criteria
- Inability to comply with the conditions of the protocol
- 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.
Where it is running
1 location listed across 1 US state.
- Cleveland Clinic - Cleveland, Ohio, United States