Stage D Heart Failure study: Sacubitril-Valsartan
Official title Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
ClinicalTrials.gov ID: NCT04191681
What this study is testing
What is Sacubitril‑Valsartan?
An investigational oral medication being studied for patients with stage D heart failure who have a left ventricular assist device. It is designed to block the angiotensin II receptor and inhibit neprilysin, which may help regulate blood pressure and fluid balance.
Also referred to as Entresto.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if sacubitril‑valsartan is safe and works well for patients who have a durable continuous‑flow LVAD, compared with the usual oral blood‑pressure‑lowering medicine.
- Who it's for
- It is looking for adults who have stage D heart failure and have had a continuous‑flow LVAD implanted.
- What's involved
- Participants will take the study drug or the usual medicine, have regular clinic visits, and undergo routine tests to monitor heart function and safety.
- Time commitment
- The study lasts about 12 months, with visits every few weeks to check health and take medication.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults (age ≥ 18 years)
- Durable CF-LVAD for any indication
- NYHA II to IV classification
- LVEF \< 40%
- Written informed consent
You likely can't join if
- 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 \ 5.4 mM at randomization, iv.
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.