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

Description

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.

Conditions

Stage D Heart Failure

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Study Overview

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Study Details

Study overview

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.

Safety and Efficacy of Angiotensin Receptor-neprilysin Inhibitor After Left Ventricular Assist Device ImplanT (SEAL-IT) Study

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

Condition
Stage D Heart Failure
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. Inability to comply with the conditions of the protocol
  • 2. Any patient with durable CF-LVAD who has any one of the following:

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Jerry D Estep, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2022-12