Actively Recruiting
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
Led by The Cleveland Clinic · Updated on 2021-06-07
50
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (age 65 18 years)
- Durable CF-LVAD for any indication
- NYHA II to IV classification
- LVEF < 40%
- Written informed consent
You will not qualify if you...
- Inability to comply with the conditions of the protocol
- 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 or parenteral diuretics in 24 hours preceding randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
J
Jerry D Estep, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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