SEAL-IT Study: Sacubitril-Valsartan for Heart Failure with LVAD
This study, called SEAL-IT, is looking at how safe and effective a medication called sacubitril-valsartan is for people with advanced heart failure (Stage D Heart Failure) who have a left ventricular assist device (LVAD) implanted. An LVAD is a pump that helps your heart circulate blood. Researchers want to see if sacubitril-valsartan works better than usual care oral vasodilator therapy (another type of heart medication) to improve your health and reduce side effects. They will measure how many people stop taking the drug due to side effects and changes in a heart biomarker called NT-proBNP over 3 months. You may be able to join if you are an adult with a durable LVAD, have certain heart failure symptoms, and your heart's pumping ability (LVEF) is less than 40%. The study is currently unclear about its recruitment status.
- Study design
- This study will involve about 50 participants. It compares sacubitril-valsartan to standard-of-care oral vasodilator therapy.
- What's involved
- Participants will have their assigned medication started or continued and then adjusted every 2-4 weeks. The study will look at outcomes at 3, 6, and 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and efficacy for 3 months, and also for long-term outcomes at 6 and 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
At a glance
Conditions
NCT04191681
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cleveland Clinic
Cleveland, Ohiostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jerry D Estep, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence of drug discontinuation from drug-related adverse events due to sacubitril-valsartan versus standard-of-care oral vasodilator therapy at 3 months3 months
Incidence of drug discontinuation from drug-related adverse events due to sacubitril-valsartan versus standard-of-care oral vasodilator therapy evaluated at 3 months. Incidence of drug discontinuation is defined as the number of patients exposed to the drug with an adverse event over the total number of patients exposed to the drug. An adverse event is defined as any one of the following: acute kidney injury with eGFR decline \> 25% from baseline, hyperkalemia with potassium \> 5.5 mM, hypotension with mean arterial pressure (MAP) \< 60 mm Hg, angioedema, dizziness, and/or cough.
- Time-averaged proportional change in NT-proBNP concentration (pg/mL) with sacubitril-valsartan versus standard-of-care oral vasodilator therapy at 3 months3 months
Time-averaged proportional change in NT-proBNP concentration (pg/mL) with sacubitril-valsartan versus standard-of-care oral vasodilator therapy evaluated at 3 months.