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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
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 moreAwards & 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
1,520 Previous Clinical Trials
503,136 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have heart problems that make it difficult for you to do everyday activities.You have a severe, active heart failure.You have been diagnosed with heart failure and are being treated by a heart specialist at the PMCC Heart Function Clinic.Your heart's pumping ability, measured by a test called echocardiography, is 40% or less.You have not been hospitalized for heart failure in the last 3 months.Criterion: You are unable to adjust medications due to the following reasons:
- History of angioedema
- Uncontrolled high blood pressure
- Low blood pressure preventing medication adjustment
- Resting heart rate less than 56 beats per minute
- Congenital heart disease
- Previous or pending heart transplant
- Recent major heart or blood vessel surgeries
- Certain heart conditions like severe valve disease or obstructive lesions
- Liver problems or impaired liver function
- Severe kidney problems
- Stenosis in both renal arteries
- Uncontrolled thyroid disorders
- Abnormal levels of potassium or sodium in the blood
- Severe asthma or pulmonary disease
- Any other conditions that the doctor feels would prevent you from participating in the study, or if your life expectancy is less than 1 yearYou 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.
Research Study Groups:
This trial has the following groups:- Group 1: Study Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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