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โ† Trials
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Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study

RecruitingPhase 4Ages 18 Years - anyAllThe Cleveland Clinic
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Adults (age โ‰ฅ 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.
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What it tests

  • Sacubitril-Valsartan
  • Usual care (standard-of-care) arm
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Where

1 site
Cleveland Clinic
Cleveland, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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