Heart Failure Clinical Trial

Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 Criteria:

Left Ventricular Ejection Fraction < 35%
Implanted cardiac device (permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), chronic resynchronization therapy (CRT), implantable loop recorder (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 is for people with:

Heart Failure

Estimated Enrollment:

30

Study ID:

NCT05900362

Recruitment Status:

Not yet recruiting

Sponsor:

Saint Luke's Health System

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There are 4 Locations for this study

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Saint Luke's Hospital of Kansas City
Kansas City Kansas, 64111, United States More Info
Sanjaya Gupta, MD
Contact
[email protected]
Sanjaya Gupta, MD
Principal Investigator
Saint Luke's South Hospital
Overland Park Kansas, 66213, United States More Info
Sanjaya Gupta, MD
Contact
816-931-1883
[email protected]
Sanjaya Gupta, MD
Principal Investigator
Saint Luke's North Hospital
Kansas City Missouri, 64154, United States More Info
Sanjaya Gupta, MD
Contact
816-931-1883
[email protected]
Sanjaya Gupta, MD
Principal Investigator
Saint Luke's East Hospital
Lee's Summit Missouri, 64086, United States More Info
Sanjaya Gupta
Contact
816-931-1883
[email protected]
Sanjaya Gupta, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

30

Study ID:

NCT05900362

Recruitment Status:

Not yet recruiting

Sponsor:


Saint Luke's Health System

How clear is this clinincal trial information?

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