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Behavioural Intervention
Medication Self-Adjustment for Atrial Fibrillation
N/A
Waitlist Available
Led By Felix Alejandro Ayala Paredes, MD PhD
Research Sponsored by Université de Sherbrooke
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, up to 1 year
Awards & highlights
Study Summary
This trial will test whether giving patients access to their device information and letting them adjust their medication leads to better heart rate control and more hours of activity.
Who is the study for?
This trial is for patients with permanent or persistent atrial fibrillation who have a Biotronik pacemaker and use the Home Monitoring system. They should be on stable rate control medication for at least six months. Those with heart failure requiring maximum beta blocker doses, or other conditions preventing medication changes cannot join.Check my eligibility
What is being tested?
The study tests if patients can self-adjust their heart rate control medications using data from their pacemakers transmitted via Home Monitoring. The goal is to see if this leads to better heart rate management and improves daily activity by empowering patients.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include symptoms related to improper heart rate such as fatigue or palpitations due to over- or under-adjustment of medications during the self-management process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6 minutes walk test
Heart rate control target
Physical activity during the day
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants in gradual self-adjustment rate control medicationExperimental Treatment1 Intervention
Patients receive a weekly simplified version of the information transmitted by the HM system. In the first 3 months, using that information, the physician changes or not the rate control medication posology (i.e. if the mean heart rate is 60bpm, betablocker dose is cut to half, and another heart rate evaluation is done a week later, and if heart rate is now 120bpm the dose is increased to a 3/4 of the initial dose, and so on). After those three initial months where physician guide titration, the patient is allowed to make self-adjustment of their medication accordingly to the information received (i.e. increasing or decreasing their rate control medication depending on heart rates and activity hours per day.
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Who is running the clinical trial?
Université de SherbrookeLead Sponsor
292 Previous Clinical Trials
69,391 Total Patients Enrolled
Felix Alejandro Ayala Paredes, MD PhDPrincipal InvestigatorSherbrooke university medical school
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot change my current medications due to other health issues.I need the highest dose of beta blocker for my heart failure.You have a specific type of pacemaker made by Biotronik that is connected to a HM system.I have had atrial fibrillation for over 6 months and am on stable medication.
Research Study Groups:
This trial has the following groups:- Group 1: Participants in gradual self-adjustment rate control medication
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this research study still ongoing?
"Clinicaltrials.gov confirms that enrollment for this medical trial has come to a close, as the study was first posted on July 1st 2022 and last modified on May 25th of the same year. Nevertheless, there are presently 477 other studies seeking patients at this moment in time."
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