Safety and Efficacy of ARNI After LVAD ImplanT (SEAL-IT) Study

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination; Valsartan; Vasodilator Agents

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.