Remote Patient Monitoring for Heart Failure

(FAST-RPM-HF Trial)

Not yet recruiting at 3 trial locations

Overseen By Valerie Rader, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Saint Luke's Health System

Disqualifiers: Implanted cardiac device, Pregnancy, End-stage renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for helping people with heart failure manage their condition from home using the VitalCare platform. Researchers aim to determine if remote patient monitoring (also known as remote physiologic monitoring or telehealth monitoring) can reduce hospital visits and improve patient engagement. Participants will use devices like a tablet and blood pressure cuff to track their health. Suitable candidates have heart failure with moderate symptoms, have been recently hospitalized for it, and are comfortable using a smartphone or tablet. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance heart failure management for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this remote patient monitoring method is safe for heart failure management?

Research shows that remote patient monitoring is generally safe for people with heart failure. Studies have found that remote monitoring tools, such as weight scales and blood pressure cuffs, do not cause serious side effects. These tools allow patients to track their health from home and have been used in other medical settings without major problems.

Remote monitoring can even help reduce hospital visits and lower the risk of heart-related issues by allowing early detection of symptoms. The equipment, like the VitalCare platform, is designed to be easy to use and reliable. Although this trial is new, similar tools have been well-received by patients in other studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote patient monitoring for heart failure because it offers a new way to manage the condition right from a patient's home. Unlike standard treatments, which often require frequent in-person visits to adjust medications or monitor symptoms, this method uses a tablet and connected devices like a weight scale and blood pressure cuff to track vital signs remotely. This approach allows for real-time data sharing with healthcare providers, potentially catching issues early and reducing hospital visits. By providing more personalized and immediate care, remote monitoring could significantly improve the quality of life for heart failure patients.

What evidence suggests that remote patient monitoring is effective for heart failure?

Research has shown that remote patient monitoring (RPM), which participants in this trial will receive, can benefit people with heart failure. Studies have found that RPM enables healthcare teams to monitor patients' health while they remain at home. This approach can reduce hospital readmissions and may even lower mortality rates for heart failure patients. By using devices like blood pressure cuffs and weight scales at home, patients can better manage their condition and detect problems early. Although early telemonitoring alone did not reduce hospital visits, it paved the way for more effective monitoring. These findings suggest RPM could be a promising tool for managing heart failure. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with heart failure who've been hospitalized for it within the last year, can use a smartphone or tablet, and speak English. It's not for pregnant individuals, those awaiting a heart transplant, with severe kidney disease or very poor heart function (LVEF < 35%), or have certain implanted cardiac devices.

Inclusion Criteria

I have moderate heart failure symptoms.

I have been diagnosed with heart failure.

Own a smartphone or tablet or comfortable with using one

Exclusion Criteria

You are waiting for a heart transplant.

My heart failure symptoms are mild or very severe.

My kidneys are in the final stage of failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote patient monitoring using the VitalCare platform for heart failure management

6 months

Monthly data review

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Remote Patient Monitoring

Trial Overview

The study tests the VitalCare platform's ability to monitor heart failure patients remotely. It aims to see if this technology improves patient engagement and reduces hospital visits due to worsening heart failure.

How Is the Trial Designed?

Group I: Interventional Experimental Treatment 1 Intervention

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

Remote Patient Monitoring is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Remote Patient Monitoring for:

• Chronic conditions such as hypertension, diabetes, asthma, COPD, congestive heart failure, and chronic kidney disease

Approved in European Union as Remote Patient Monitoring for:

• Cardiovascular diseases, diabetes, asthma, COPD, and chronic kidney disease

Approved in Canada as Remote Patient Monitoring for:

• Chronic conditions such as hypertension, diabetes, asthma, COPD, and chronic kidney disease

Who Is Running the Clinical Trial?

Saint Luke's Health System

Lead Sponsor

Trials

42

Recruited

12,600+

Published Research Related to This Trial

The CardioMEMS device, an implantable sensor for remote monitoring of heart function, has shown promising results in preventing hospitalizations for chronic heart failure (HF) patients, particularly those who were hospitalized in the previous year and classified as New York Heart Association functional class III.

Current telemonitoring methods using traditional non-hemodynamic parameters have produced inconsistent results, highlighting the need for advanced monitoring technologies like CardioMEMS to improve patient outcomes and reduce hospital resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote monitoring of chronic heart failure patients: invasive versus non-invasive tools for optimising patient management. Veenis, JF., Brugts, JJ.[2020]

Remote patient monitoring (RPM) has the potential to significantly improve the outpatient management of heart failure (HF) by addressing gaps in evidence-based therapies and enhancing the prediction and management of clinical decompensation.

The review highlights key components of effective RPM, including patient data collection and analysis, and identifies emerging digital tools that could enhance clinical efficacy in HF management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Patient Monitoring in Heart Failure: Factors for Clinical Efficacy. Bhatia, A., Maddox, TM.[2022]

Remote monitoring of hemodynamic parameters in heart failure patients has shown initial success in improving clinical outcomes, suggesting it may be a valuable tool in managing the condition.

In contrast, using daily weight monitoring alone has not demonstrated broad benefits in larger studies, indicating that more complex, multi-parameter approaches may be necessary for effective heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Physiologic Monitoring for Heart Failure. Ali, O., Hajduczok, AG., Boehmer, JP.[2022]

The proposed remote monitoring system for Congestive Heart Failure (CHF) patients effectively utilizes a Decision Support System (DSS) with machine learning to predict decompensations and assess heart failure severity, achieving an accuracy of 71.9% and 81.3%, respectively.

The system's custom-designed sensors for home monitoring provide reliable data comparable to established literature, supporting the use of heart rate variability (HRV) as a promising method for distinguishing between healthy individuals and CHF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-layer monitoring system for clinical management of Congestive Heart Failure. Guidi, G., Pollonini, L., Dacso, CC., et al.[2018]

Remote monitoring (RM) of heart failure patients who are not homebound can be effectively implemented, as shown in a pilot study involving 150 participants from Massachusetts General Hospital over 6 months.

While the RM group showed a lower readmission rate compared to the usual care group, the difference was not statistically significant, suggesting that RM may help reduce hospital readmissions for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of remote monitoring to improve outcomes in patients with heart failure: a pilot trial. Kulshreshtha, A., Kvedar, JC., Goyal, A., et al.[2021]

Telemonitoring and remote monitoring of heart failure patients using devices that track vital signs like weight, heart rate, and blood pressure can help healthcare professionals manage care more effectively, but current methods have not shown a significant impact on patient outcomes.

Investigational devices that measure cardiac hemodynamic status through invasive pressure monitoring may improve the ability to predict heart failure events, suggesting a potential advancement in managing refractory heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring in chronic heart failure. Hasan, A., Paul, V.[2022]

The TIM-HF2 trial, involving 1571 heart failure patients, demonstrated that remote patient management significantly reduced the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death compared to usual care, with a reduction from 6.64% to 4.88%.

Patients receiving remote management had a lower all-cause death rate of 7.86 per 100 person-years compared to 11.34 per 100 person-years in the usual care group, indicating that this intervention may enhance patient outcomes in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Koehler, F., Koehler, K., Deckwart, O., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10038166/

Remote Patient Monitoring to Improve Outcomes in Heart ...

RPM supports medical care and early interventions to potentially promote patient's disease management and improve outcomes.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9536717/

Remote Patient Monitoring in Heart Failure - PubMed Central

Remote patient monitoring (RPM) aims to address these gaps in current HF care. RPM is a strategy that allows care teams to monitor and manage patients outside ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0147956324000049

Telehealth care and remote monitoring strategies in heart ...

This meta-analysis provides insights about telemonitoring on heart failure patients. Telemonitoring reduces mortality and rehospitalization in hearth failure ...

4.

hfsa.org

hfsa.org/sites/default/files/media/2019/02/PIIS1071916418310625-remote.pdf

Remote Monitoring of Patients With Heart Failure

Practical aspects around RPM technology include targeting of risk populations, hav- ing mechanisms to ensure patient adherence to monitoring, and health care ...

5.

jacc.org

jacc.org/doi/10.1016/j.jacc.2023.04.010

Remote Monitoring for Heart Failure Management at Home

Early telemonitoring of weights and symptoms did not decrease heart failure hospitalizations but helped identify steps toward effective monitoring programs.

6.

uscjournal.com

uscjournal.com/articles/remote-monitoring-heart-failure-revolutionizing-patient-management-and-outcomes?language_content_entity=en

Remote Monitoring in Heart Failure: Patient Management ...

RM is a promising approach for monitoring physiological parameters to preemptively identify negative changes before HF patients experience clinical ...

7.

ajmc.com

ajmc.com/view/remote-monitoring-may-improve-heart-failure-outcomes-with-anitha-vijayan-md

Remote Monitoring May Improve Heart Failure Outcomes

Remote patient monitoring can improve GDMT adherence for HFrEF by overcoming barriers like transportation and inadequate follow-up. Start-up ...