Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

Congestive Heart Failure Clinical Trial

— FAST-RPM-HF  

Official title:

Feasibility and Success Trial of Remote Patient Monitoring in Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05900362
• Other study ID #: 1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: June 2024
• Source: Saint Luke's Health System
• Contact: Sanjaya Gupta, MD
• Phone: 8169311883
• Email: sgupta[@]saint-lukes.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• VitalCare Platform
All participants will receive an VitalCare platform with tablet, Eko Duo with capability to record heart/lung sounds, blood pressure cuff, pulse oximetry and digital scale

Locations

Country	Name	City	State
United States	Saint Luke's Hospital of Kansas City	Kansas City	Kansas
United States	Saint Luke's North Hospital	Kansas City	Missouri
United States	Saint Luke's East Hospital	Lee's Summit	Missouri
United States	Saint Luke's South Hospital	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Saint Luke's Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with monitoring protocol	Actual rate of completed patient data transmissions is greater than or equal to 60% of the expected rate of patient data transmissions (BP, HR, Weight, EKG)	6 month
Secondary	Patient engagement as measured by Patient Activation Measure	Patient engagement as measured by the Patient Activation Measure will increase by 1 or more points from baseline to 6 months. The PAM score ranges from 1 to 100 corresponding to 1 of 4 levels of patient engagement. Higher numbers correlate with greater patient engagement.	6 months
Secondary	Heart failure hospitalizations, emergency room visits for Heart Failure as compared to prior to trial enrollment	Patients who undergo remote patient monitoring via the VitalCare platform will have a lower rate of hospitalization for heart failure and lower rate of emergency room presentation for heart failure symptoms as compared to previous rate of heart failure hospitalization and emergency room presentations for heart failure symptoms for the 6 months prior to trial enrollment	6 month