Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure (FAST-RPM-HF)

Saint Luke's Health System

Status: Not yet enrolling

Conditions: Congestive Heart Failure

Treatments: Device: VitalCare Platform

Study type: Interventional

Funder types: Other

Identifiers

NCT05900362

1

Details and patient eligibility

About

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.

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Interventional

Experimental group

Description:

All patients receive the VitalCare platform with a tablet computer, an Eko Duo device, a weight scale, a blood pressure cuff, a pulse oximeter

Treatment:

Device: VitalCare Platform