RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-11-08
Study Completion:2022-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04191681

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults (age ≥ 18 years)
  2. 2. Durable CF-LVAD for any indication
  3. 3. NYHA II to IV classification
  4. 4. LVEF \< 40%
  5. 5. Written informed consent
  1. 1. Inability to comply with the conditions of the protocol
  2. 2. Any patient with durable CF-LVAD who has any one of the following:

Contacts and Locations

Study Contact

Jerry D Estep, MD
CONTACT
216-444-7646
estepj@ccf.org

Principal Investigator

Jerry D Estep, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Jerry D Estep, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-08
Study Completion Date2022-12

Study Record Updates

Study Start Date2019-11-08
Study Completion Date2022-12

Terms related to this study

Keywords Provided by Researchers

  • continuous flow left ventricular assist device
  • sacubitril-valsartan
  • oral vasodilator
  • Heart failure

Additional Relevant MeSH Terms

  • Stage D Heart Failure