NCT04191681RecruitingPhase 4
Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study
Safety and Efficacy of Angiotensin Receptor-neprilysin Inhibitor After Left Ventricular Assist Device ImplanT (SEAL-IT) Study
Source: ClinicalTrials.gov · Last updated 7 Jun 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 18 Nov 2019
- Start date
- 8 Nov 2019
- Primary completion date
- Mar 2022
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Heart failure
- NCT number
- NCT04191681
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 8 Nov 2019 to the primary completion date, Mar 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to comply with the conditions of the protocol
Lab values
- Any patient with durable CF-LVAD who has any one of the following:
- 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 (e.g., dobutamine, dopamine, epinephrine, norepinephrine, phenylephrine, vasopressin, nitroglycerin, nitroprusside, epoprostenol) or parenteral diuretics in 24 hours preceding randomization.
Who the study is looking for
- Adults (age ≥ 18 years)
- Durable CF-LVAD for any indication
- NYHA II to IV classification
- LVEF \< 40%
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.