Telemonitoring for Heart Failure

(Medly Titrate Trial)

Overseen By Veronica Kirk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must be taking: Ace inhibitors, Beta blockers

Disqualifiers: Congenital heart disease, Heart transplant, 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: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether telemonitoring (remote health tracking via smartphone) can manage heart failure more effectively than regular in-office visits. The focus is on adjusting heart failure medications safely and efficiently by providing real-time data to doctors and patients. Suitable candidates have stable heart failure, are not yet on maximum medication doses, and receive care at a specific heart clinic in Toronto. Participants will either use the telemonitoring system or continue with their usual in-office visits for comparison. As an unphased study, this trial offers a unique opportunity to contribute to innovative heart failure care solutions.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it focuses on adjusting heart failure medications to reach target doses, so you may need to continue your current heart failure medications while they are adjusted.

What prior data suggests that telemonitoring is safe for heart failure patients?

Research has shown that heart failure patients generally receive telemonitoring well. Studies have found that telemonitoring can reduce deaths and hospital visits, suggesting it is relatively safe.

Detailed information about specific side effects from telemonitoring remains limited. However, its ability to lower hospital visits indicates it is a helpful and safe way to manage heart failure at home. Although large studies have not yet tested telemonitoring, smaller studies suggest it improves health outcomes without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about telemonitoring for heart failure because it offers a fresh approach compared to traditional in-office visits. Unlike standard management strategies that require patients to physically go to their doctor's office, telemonitoring uses remote titration management via telephone and data from devices like the Medly system. This method allows for continuous monitoring and adjustment of treatment from the comfort of a patient's home, potentially leading to more timely interventions and better management of heart failure symptoms. This can significantly improve patient convenience and may lead to better overall health outcomes.

What evidence suggests that telemonitoring is effective for heart failure?

This trial will compare telemonitoring with standard in-office visits for managing heart failure. Studies have shown that telemonitoring, which participants in the study group will receive, can help people with heart failure by lowering death rates and reducing hospital readmissions. Research indicates that remote monitoring tools allow for better management of the condition by providing healthcare providers with real-time information. This information helps doctors adjust medications more effectively and quickly. Telemonitoring has improved outcomes by preventing hospital readmissions and offering a reliable way for patients to manage their health at home. Overall, evidence supports telemonitoring as a valuable tool in treating heart failure. ^{2 5 6 7 8}

Who Is on the Research Team?

Emily Seto, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults with heart failure (NYHA Class II-III) who are not yet on target doses of heart failure medication, can give informed consent, speak and read English well enough to use the Medly app, and have a left ventricular ejection fraction of 40% or less. They should be stable with no recent hospitalizations and able to use the telemonitoring equipment.

Inclusion Criteria

You have heart problems that make it difficult for you to do everyday activities.

Patient is able to provide informed consent to participate in the program

Patient or their informal caregiver speaks and reads English adequately to participate in the program and understand the alerts/prompts in the Medly application

Exclusion Criteria

Patients will be excluded from the study based on the clinical judgment of their healthcare provider

Already on target doses of guideline-directed medical therapy (GDMT)

You have a severe, active heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telemonitoring-based medication titration for heart failure management

6 months

Telephone contacts at 2-week intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Implementation Evaluation

Qualitative interviews with patients and providers to assess implementation barriers and facilitators

Throughout study completion

What Are the Treatments Tested in This Trial?

Interventions

• Telemonitoring

Trial Overview The study tests if using a smartphone-based telemonitoring system called Medly can help patients adjust their heart failure medications better than regular in-office visits. It's a randomized controlled trial comparing these two strategies at the Peter Munk Cardiac Centre.

How Is the Trial Designed?

Group I: Study Group Experimental Treatment 1 Intervention

Remote titration management strategy, consisting of telephone contacts, which will utilize data from the Medly system.

Group II: Control Group Active Control 1 Intervention

Standard titration management strategy, consisting of regular in-office visits.

Telemonitoring is already approved in Canada, European Union, United States for the following indications:

Approved in Canada as Telemonitoring for:

• Heart Failure
• Diabetes
• Hypertension
• COPD
• Depression

Approved in European Union as Telemonitoring for:

• Heart Failure
• Diabetes
• Hypertension
• COPD

Approved in United States as Telemonitoring for:

• Heart Failure
• Diabetes
• Hypertension
• COPD

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9808028/

Telemonitoring in heart failure patients: Systematic review ... Home telemonitoring has been used as a modality to prevent readmission and improve outcomes for patients with heart failure.

2. 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 ...

3. 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 ... Effectiveness of remote patient monitoring after discharge of hospitalized patients with heart failure: BEAT-HF. JAMA Intern Med 2016;176:310–8.

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2488923

Effectiveness of Remote Patient Monitoring After Discharge ... Importance It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure (HF) after hospitalization.

5. jmir.org jmir.org/2017/1/e18/

Remote Monitoring of Patients With Heart Failure Telemonitoring and home telehealth appear generally effective in reducing heart failure rehospitalization and mortality.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10424885/

Telemonitoring for heart failure: a meta-analysis - PMC Telemonitoring modalities in heart failure (HF) have been proposed as being essential for future organization and transition of HF care, ...

7. 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.

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1010029

Telemonitoring in Patients with Heart Failure Small studies suggest that telemonitoring may improve heart-failure outcomes, but its effect in a large trial has not been established.