Hospital Admission in Heart Failure: Readiness for Discharge and Predicting Future Admissions

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: 11-002371
    Sponsor Protocol Number: 11-002371

About this study

The purpose of this study is to identify measures of heart rate and heart rate variability responses to changes in nervous system activity, breathing variability, and lung fluid in HF patients as early as possible in the course of their hospital admission and subsequently just prior to discharge, using a simplified approach, in order to determine if these measures can assess readiness for discharge and more accurately predict likelihood for readmission.

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:

  • Patients with New York Heart Association (NYHA) class I-IV HF, regardless of left ventricular functional status.
    • These patients will be on stable doses of optimized medications (including β-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and diuretics) for at least 1 month prior to enrollment.
  • Subjects with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive, subjects with skin breakdown in areas on the chest where device placement is required or subjects with Neurostimulators will also not be able have thoracic fluid status accessed using the µ-cor device, but could complete all other parts of the study.
  • The majority of patients will be recruited from the Heart Failure Clinic and the Cardiovascular Health Clinic (CVHC) in the Division of Cardiovascular Diseases of Mayo Clinic, as well as from the surrounding community.

Exclusion Criteria:

  • Subjects recruited must not be pregnant or trying to become pregnant (this will be confirmed with a blood pregnancy test at the SMH CRU before any testing begins).

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bruce Johnson, Ph.D.

Open for enrollment

Contact information:

Briana Ziegler

(507)255-7125

Ziegler.Briana@mayo.edu

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CLS-20317848

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