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Telemonitoring for Heart Failure

N/A
Waitlist Available
Led By Emily Seto, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
New York Heart Association (NYHA) Class II-III
Diagnosed with HF and followed by a cardiologist at the PMCC Heart Function Clinic, who has primary responsibility for management of the patient's HF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will evaluate the effectiveness and safety of using telemonitoring to facilitate medication titration for heart failure, and the factors that can positively impact the implementation of this intervention.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on monitoring rather than new medications, side effects may relate more to issues with technology use such as privacy concerns or data inaccuracies rather than typical drug side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have heart problems that make it difficult for you to do everyday activities.
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You have been diagnosed with heart failure and are being treated by a heart specialist at the PMCC Heart Function Clinic.
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You have not been hospitalized for heart failure in the last 3 months.
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You are not taking the right amount of specific heart failure medications yet, and it will take at least 2 months to reach the correct doses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of clinic visits required to achieve GDMT titration completion
The proportion of patients achieving GDMT titration completion
Secondary outcome measures
Implementation barriers
Implementation facilitators
Median time to GDMT titration completion
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Study GroupExperimental Treatment1 Intervention
Remote titration management strategy, consisting of telephone contacts, which will utilize data from the Medly system.
Group II: Control GroupActive Control1 Intervention
Standard titration management strategy, consisting of regular in-office visits.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medly
2016
N/A
~100

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,691 Total Patients Enrolled
25 Trials studying Heart Failure
17,414 Patients Enrolled for Heart Failure
Emily Seto, PhDPrincipal InvestigatorUniversity Health Network, Toronto
2 Previous Clinical Trials
140 Total Patients Enrolled
1 Trials studying Heart Failure
90 Patients Enrolled for Heart Failure

Media Library

Telemonitoring Clinical Trial Eligibility Overview. Trial Name: NCT04205513 — N/A
Heart Failure Research Study Groups: Study Group, Control Group
Heart Failure Clinical Trial 2023: Telemonitoring Highlights & Side Effects. Trial Name: NCT04205513 — N/A
Telemonitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT04205513 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~18 spots leftby Mar 2025