Telemonitoring for Heart Failure

Overseen By Erick S Romero, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Inability to consent, Smartphone use, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The study aims to test the hypothesis that multi-omics studies can identify Heart Failure profiles at risk of adverse outcomes and evaluate a telemonitoring intervention in the optimization of guideline-directed medical therapy.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Telemonitoring devices for Heart Failure?

Research shows that remote monitoring devices can help reduce hospital readmissions and improve patient outcomes by allowing early detection of worsening heart failure and timely medical interventions. These devices empower patients to manage their health at home, potentially reducing healthcare costs and improving quality of life. ^{1 2 3 4 5}

Is telemonitoring safe for heart failure patients?

Telemonitoring is considered safe for heart failure patients, as it allows health-care providers to monitor patients' health data remotely without causing harm. ^{1 6 7 8 9}

How does telemonitoring for heart failure differ from other treatments?

Telemonitoring for heart failure is unique because it uses remote monitoring devices to track patients' health data and send it to healthcare providers, allowing for timely interventions. This approach can help reduce hospitalizations by managing patients' conditions more effectively at home, unlike traditional treatments that may not offer continuous monitoring. ^{1 8 10 11 12}

Research Team

Martin Cadeiras, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for individuals with heart failure who have evidence of cardiac issues or high levels of a specific heart stress marker. They must be in any stage or class of heart failure, able to consent, follow the study's protocol, use a smartphone regularly, and not have had a heart transplant or mechanical circulatory support.

Inclusion Criteria

My heart failure is between stages B to D and class I to IV.

I have been diagnosed with heart failure.

I have heart issues shown by tests or high BNP levels.

Exclusion Criteria

I can follow the study's rules and attend all required visits.

I am unable to give consent by myself.

You are using a mechanical circulatory support device.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Longitudinal Profiling

Longitudinal profiling based on clinical data and multi-omics studies

5 years

Telemonitoring Intervention

Randomization of a telemonitoring intervention to optimize guideline-directed medical therapy

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Telemonitoring devices

Trial Overview The study is exploring if advanced testing can predict which patients with heart failure are at higher risk and whether monitoring these patients using telemonitoring devices can help optimize their treatment according to established guidelines.

Participant Groups

Group I: Telemonitoring Experimental Treatment 1 Intervention

Blood pressure and heart rate monitoring, scale, activity tracker.

Group II: No intervention Active Control 1 Intervention

No intervention.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

Remote patient monitoring (RPM) for heart failure patients allows for the wireless transmission of vital physiological data to healthcare providers, enabling timely interventions when health metrics exceed safe thresholds.

The use of various RPM devices, including scales and blood pressure monitors, can enhance patient engagement in their cardiovascular care and may help alleviate the overall burden of heart failure on healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Monitoring Devices and Heart Failure. Gupta, K., Mastoris, I., Sauer, AJ.[2023]

The iGetBetter system, a mobile and web-based remote monitoring program, was found to be feasible for self-managing heart failure in a pilot study of 21 patients over 90 days, with high engagement and satisfaction reported by participants.

While the program improved patients' confidence in managing their health and communication with healthcare providers, it did not significantly reduce hospitalizations or improve heart failure-related quality of life compared to matched controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient engagement with a mobile web-based telemonitoring system for heart failure self-management: a pilot study. Zan, S., Agboola, S., Moore, SA., et al.[2018]

Heart failure is a growing medical issue, and frequent self-monitoring of patients' clinical and physiological variables at home could help stabilize their condition and reduce hospitalizations.

Remote monitoring of pulmonary artery pressure using percutaneously implanted devices may provide an early warning for cardiac decompensation, allowing for timely adjustments in treatment and potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote telemonitoring for patients with heart failure: might monitoring pulmonary artery pressure become routine? Hutchinson, K., Pellicori, P., Dierckx, R., et al.[2014]

Telemetric monitoring of patients with implantable cardioverter-defibrillators (ICDs) can significantly reduce the number of outpatient and inpatient visits, as well as the rate of inadequate therapies, by allowing for early detection of device issues and cardiac arrhythmias.

While remote monitoring has been associated with a reduction in all-cause mortality due to timely interventions, there is currently no evidence that therapy guided by telemetric data improves patient outcomes, highlighting the need for better integration of telemonitoring in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Telemonitoring of implanted cardiac devices : Clinical necessity or senseless luxury?] Döring, M., Richter, S., Knopp, H., et al.[2019]

Patients in a mobile phone-based telemonitoring program for heart failure showed an overall adherence rate of 73.6% for taking prescribed home readings, but this rate declined by 1.4% per month, indicating a need for strategies to maintain engagement over time.

Older patients demonstrated higher adherence rates compared to younger patients, and factors such as perceived benefits, ease of use, and social support significantly influenced adherence, suggesting that tailored interventions could enhance patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Adherence to a Mobile Phone-Based Heart Failure Telemonitoring Program: A Longitudinal Mixed-Methods Study. Ware, P., Dorai, M., Ross, HJ., et al.[2023]

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]

In a study involving 191 patients with chronic heart failure, telemonitoring (TM) significantly reduced hospitalizations for heart failure compared to traditional monitoring, indicating its effectiveness in managing patients with CRT-D devices.

While TM did not affect overall mortality or cardiac death rates, it was identified as a key predictor of hospitalizations, suggesting it plays a crucial role in monitoring and potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring in heart failure patients treated by cardiac resynchronisation therapy with defibrillator (CRT-D): the TELECART Study. Sardu, C., Santamaria, M., Rizzo, MR., et al.[2022]

In a study of 150 stable heart failure patients using a telemonitoring platform, adherence to weight transmissions was high at 74%, which was associated with fewer hospitalizations for heart failure in the six months prior to enrollment.

Despite high initial adherence, the use of the personal health record declined significantly over the year, indicating a need for strategies to maintain patient engagement in telemonitoring over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns in the Use of Heart Failure Telemonitoring: Post Hoc Analysis of the e-Vita Heart Failure Trial. Brons, M., Ten Klooster, I., van Gemert-Pijnen, L., et al.[2023]

In a study involving 120 patients with chronic heart failure, telemonitoring using mobile phone technology significantly reduced hospitalizations for worsening heart failure by 50% compared to standard treatment, with a relative risk reduction of 54% in patients who successfully used the technology.

Patients in the telemonitoring group also experienced shorter hospital stays when they were admitted, averaging 6.5 days compared to 10 days for the control group, indicating that telemonitoring not only helps prevent hospitalizations but may also lead to better management during hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. Scherr, D., Kastner, P., Kollmann, A., et al.[2022]

Heart failure affects around 26 million people globally, leading to poor quality of life and frequent hospitalizations, which create a significant economic burden on healthcare systems.

Telemonitoring, particularly through non-invasive devices, is being explored as a promising strategy to improve management and outcomes for heart failure patients, although the effectiveness of these devices still needs further clarification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of non-invasive devices for the telemonitoring of heart failure patients. Faragli, A., Abawi, D., Quinn, C., et al.[2021]

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]

The E-care telemedicine platform, which uses medical sensors to monitor vital signs in real-time, was successfully tested on 180 elderly patients with heart failure, demonstrating its ability to generate relevant alerts for at-risk situations.

Health professionals reported high satisfaction with the E-care system, which not only validated the technology but also showed potential in preventing hospitalizations by enabling timely interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experimentation of an e-platform to detect situations at risk of cardiac impairment (platform E-care) in an internal medicine unit]. Andrès, E., Talha, S., Benyahia, A., et al.[2017]

References

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

Remote Monitoring Devices and Heart Failure. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Patient engagement with a mobile web-based telemonitoring system for heart failure self-management: a pilot study. [2018]

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

Remote telemonitoring for patients with heart failure: might monitoring pulmonary artery pressure become routine? [2014]

4. Germany pubmed.ncbi.nlm.nih.gov

[Telemonitoring of implanted cardiac devices : Clinical necessity or senseless luxury?] [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Patient Adherence to a Mobile Phone-Based Heart Failure Telemonitoring Program: A Longitudinal Mixed-Methods Study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Telemonitoring in chronic heart failure. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Telemonitoring in heart failure patients treated by cardiac resynchronisation therapy with defibrillator (CRT-D): the TELECART Study. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Patterns in the Use of Heart Failure Telemonitoring: Post Hoc Analysis of the e-Vita Heart Failure Trial. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. [2022]

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

The role of non-invasive devices for the telemonitoring of heart failure patients. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

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

12. France pubmed.ncbi.nlm.nih.gov

[Experimentation of an e-platform to detect situations at risk of cardiac impairment (platform E-care) in an internal medicine unit]. [2017]