Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

Last updated: June 5, 2024
Sponsor: Saint Luke's Health System
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hyponatremia

Heart Failure

Chest Pain

Treatment

VitalCare Platform

Clinical Study ID

NCT05900362
1
  • Ages 18-80
  • All Genders

Study Summary

Previous research has investigated the use of remote patient monitoring in various clinical contexts, however there has not been a clinical trial examining use of the VitalCare platform for ambulatory management of heart failure. This trial will serve as a pilot study examining the feasibility of use of the VitalCare platform for ambulatory heart failure management and examine the effect of remote patient monitoring on patient engagement. To the investigators' knowledge, this will be the first study examining the effect of remote patient monitoring with the VitalCare platform on heart failure clinical outcomes, such as hospitalization for heart failure exacerbations and emergency room visits for heart failure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A clinical diagnosis of heart failure

  • New York Heart Association Class II or III congestive HF symptoms

  • Admission to hospital within 12 months for symptomatic heart failure.

  • Own a smartphone or tablet or comfortable with using one

  • English as primary language

  • Able to provide informed consent

Exclusion

Exclusion Criteria:

  • Left Ventricular Ejection Fraction < 35%

  • Implanted cardiac device (permanent pacemaker (PPM), implantable cardioverterdefibrillator (ICD), chronic resynchronization therapy (CRT), implantable looprecorder (ILR))

  • CardioMEMS

  • Left ventricular assist device (LVAD)

  • NYHA Class I or IV congestive HF symptoms

  • Listed for cardiac transplant

  • Pregnant at time enrollment

  • End-stage renal disease

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: VitalCare Platform
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
April 30, 2026

Study Description

The next step in determining the role of remote patient monitoring in the management of patients with heart failure is to better understand which patients are most likely to benefit from a more intensive outpatient management or simply conservative management. The subject population is patients with mild HFrEF or HFpEF who are prone to readmission. This patient population does not have implanted devices to supply objective data to evaluate patient's volume status and therefore can be challenging to manage on an outpatient basis. By providing regular data on weight, blood pressure, pulse oximetry, electrocardiogram and heart/lung sounds that is reviewed on a monthly basis, this may allow a clinician greater insight into their patient's clinical status and allow for a more accurate and timely intervention to prevent clinical deterioration. Furthermore, this should enhance patient engagement with their own health as well as with their healthcare provider. This study would significantly add to the current knowledge of management of heart failure in an ambulatory patient population without implanted devices.

Connect with a study center

  • Saint Luke's Hospital of Kansas City

    Kansas City, Kansas 64111
    United States

    Site Not Available

  • Saint Luke's South Hospital

    Overland Park, Kansas 66213
    United States

    Site Not Available

  • Saint Luke's North Hospital

    Kansas City, Missouri 64154
    United States

    Site Not Available

  • Saint Luke's East Hospital

    Lee's Summit, Missouri 64086
    United States

    Site Not Available

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