Remote Patient Monitoring for Heart Failure

(FAST-RPM-HF Trial)

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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Remote Patient Monitoring for Heart Failure?

Research shows that remote patient monitoring can reduce hospital readmissions and lower mortality rates in heart failure patients by allowing early detection of symptoms and prompt treatment. A meta-analysis found that patients using remote monitoring had a significantly lower risk of death compared to those receiving usual care. ^{1 2 3 4 5}

Is remote patient monitoring safe for humans?

Remote patient monitoring, used for heart failure, has been shown to be safe and can reduce hospital readmissions and deaths. It involves collecting and transmitting health data like weight and heart rate to healthcare providers, who can then make informed decisions about care. ^{1 2 4 6 7}

How does remote patient monitoring differ from other treatments for heart failure?

Remote patient monitoring for heart failure is unique because it uses technology to track patients' vital signs like weight, heart rate, and blood pressure from a distance, allowing healthcare providers to intervene quickly if needed. This approach can help reduce hospital visits and improve patient management by providing continuous data, unlike traditional treatments that rely on in-person visits. ^{1 6 7 8 9}

Eligibility Criteria

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.

Own a smartphone or tablet or comfortable with using one

I have been diagnosed with heart failure.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Use of remote monitoring to improve outcomes in patients with heart failure: a pilot trial. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Remote Patient Monitoring in Heart Failure: Factors for Clinical Efficacy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Telemonitoring in chronic heart failure: a systematic review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A meta-analysis of remote patient monitoring for chronic heart failure patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Remote Physiologic Monitoring for Heart Failure. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A multi-layer monitoring system for clinical management of Congestive Heart Failure. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Telemonitoring in chronic heart failure. [2022]