NCT04191681 Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
| NCT ID | NCT04191681 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Cleveland Clinic |
| Condition | Stage D Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2019-11-08 |
| Primary Completion | 2022-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2019-11-08 with a primary completion date of 2022-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Jerry D Estep, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT04191681 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stage D Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04191681 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04191681 currently recruiting?
Yes, NCT04191681 is actively recruiting participants. Contact the research team at estepj@ccf.org for enrollment information.
Where is the NCT04191681 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT04191681 clinical trial?
NCT04191681 is sponsored by The Cleveland Clinic. The principal investigator is Jerry D Estep, MD at The Cleveland Clinic. The trial plans to enroll 50 participants.
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