Evaluating sacubitril-valsartan for heart failure patients with LVADs
Safety and Efficacy of Angiotensin Receptor-neprilysin Inhibitor After Left Ventricular Assist Device ImplanT (SEAL-IT) Study
This study is testing if a new heart medication called sacubitril-valsartan is safe and effective for adults with severe heart failure who have a special heart pump called an LVAD.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04191681 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the safety and efficacy of sacubitril-valsartan, an angiotensin receptor-neprilysin inhibitor, in patients who have undergone implantation of a continuous flow left ventricular assist device (CF-LVAD). Participants will be monitored for short-term (3 months) and long-term (6 and 12 months) outcomes compared to standard oral vasodilator therapy. The study will include adults with stage D heart failure and will evaluate how well the new treatment is tolerated and its effectiveness in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a durable CF-LVAD and NYHA classification II to IV.
Not a fit: Patients with symptomatic hypotension, severely reduced kidney function, or a history of adverse reactions to similar medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves heart failure management in patients with LVADs.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jerry D Estep, MD — The Cleveland Clinic
- Study coordinator: Jerry D Estep, MD
- Email: estepj@ccf.org
- Phone: 216-444-7646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.