Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-010978
    NCT ID: NCT03387163
    Sponsor Protocol Number: HEORUSV200695

About this study

Real-world evidence of the clinical course of patient symptoms following initiation of sacubitril/valsartan via PROs with a patient-centered study design will provide important evidence of potentially beneficial outcomes associated with the use of this therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Diagnosis of chronic systolic HF
  • Active care by a provider in a healthcare system connected to a PCORnet data partner
  • Ability to speak and read English (given the use of the English ePRO technology)
  • Newly initiating sacubitril/valsartan (observational sacubitril/valsartan treatment group only - within 1 week of first dose)
  • At least a 25% change ACE/ARB dose in the last 6 months (comparator group only)
  • Reliable access to the internet

Exclusion Criteria:

  • Inability to provide informed consent
  • Life expectancy < 6 months
  • For comparator group patients: Physician documentation of planned initiation of sacubitril/valsartan within 12 weeks

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shannon Dunlay, M.D., M.S.

Open for enrollment

Contact information:

Laura Kveene

(507)422-5241

Kveene.Laura@mayo.edu

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CLS-20412974

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