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Telemonitoring for Heart Failure (Medly Titrate Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,523 Previous Clinical Trials
503,230 Total Patients Enrolled
26 Trials studying Heart Failure
17,514 Patients Enrolled for Heart Failure
Emily Seto, PhDPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
490 Total Patients Enrolled
2 Trials studying Heart Failure
440 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
~16 spots leftby Nov 2025
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