Medication Self-Adjustment for Atrial Fibrillation

Overseen By Felix Alejandro Ayala Paredes, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must be taking: Rate control

Disqualifiers: Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help patients with atrial fibrillation, a condition causing irregular heartbeats, manage their medication more effectively. Using a remote monitoring system, patients will adjust their medication weekly based on heart rate and activity levels. The goal is to empower patients to find the right medication balance to improve their daily lives. Candidates include those with a Biotronik pacemaker and stable medication for six months. As an unphased trial, this study offers patients the chance to actively participate in innovative research that could enhance medication management and overall quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it seems you will continue taking your rate control medication and adjust it gradually with guidance.

What prior data suggests that this self-adjustment of medication is safe for patients with atrial fibrillation?

Research shows that people with atrial fibrillation (AF) can safely manage their own medication. One study found that patients who managed their blood-thinning medication experienced fewer health issues overall, suggesting that self-management can be effective.

In this trial, patients will gradually learn to adjust their heart rate medication independently. They will use information from a device that monitors their heart rate and activity. Initially, doctors will assist with the adjustments, and then patients will assume control. This gradual process ensures safety and understanding.

Although specific data for this exact method is not available, similar self-management approaches have proven safe, indicating it is likely a safe option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it empowers patients with atrial fibrillation to take an active role in managing their medication. Unlike the standard treatment options where dosage adjustments are solely doctor-driven, this approach allows patients to self-adjust their medication based on real-time heart rate data and activity levels. This personalized and dynamic management could lead to more precise control of symptoms and potentially improve patients' quality of life by fostering greater autonomy and engagement in their own care.

What evidence suggests that self-adjustment of medication is effective for atrial fibrillation?

Research has shown that self-care methods for atrial fibrillation (AF) can help patients manage their condition more effectively. A review of studies found that methods like checking one's own heart rate and adjusting medication can help maintain a steady heart rhythm. In this trial, participants will gradually self-adjust their rate control medication, initially guided by a physician and later independently, based on heart rate and activity levels. Another study found that online self-management programs for AF improved patients' ability to handle their condition and boosted their mental well-being. Keeping AF under control is important because it lowers the risk of stroke and heart failure. This suggests that empowering patients to adjust their medication can lead to better heart rate control and a more active lifestyle. ^{1 6 7 8 9}

Who Is on the Research Team?

Felix Alejandro Ayala Paredes, MD PhD

Principal Investigator

Sherbrooke university medical school

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

I cannot change my current medications due to other health issues.

I need the highest dose of beta blocker for my heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment and Monitoring

Participants receive weekly simplified information from the HM system, and physicians adjust rate control medication based on heart rate and activity data.

12 weeks

Weekly remote monitoring

Self-adjustment Phase

Participants self-adjust their rate control medication based on the information received from the HM system.

9 months

Weekly remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Self-adjustment of medication

Trial Overview 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.

How Is the Trial Designed?

Group I: Participants in gradual self-adjustment rate control medication Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Published Research Related to This Trial

A review of 555 atrial fibrillation self-management apps found only five that met the criteria for inclusion, indicating a significant lack of high-quality options for patients.

The included apps generally offered basic functions like educational content and medication tracking but were rated as poor to acceptable in quality, lacked intuitive design, and none had undergone clinical trials, highlighting the urgent need for better, clinically validated mHealth interventions for atrial fibrillation management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atrial fibrillation self-management: a mobile telephone app scoping review and content analysis. Pearsons, A., Hanson, CL., Gallagher, R., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11144727/

Assessing the impact of atrial fibrillation self-care ... This systematic review evaluates the efficacy of self-care interventions for atrial fibrillation (AF), focusing on strategies for maintenance, monitoring, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8014277/

Effect of a virtual self‐management intervention for atrial ... Findings from this proof‐of‐concept study indicate that a virtual self‐management program for persons with AF may improve disease self‐management, mental health ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.124.013236

Nurse-Led Multicomponent Behavioral Activation ... The nurse-led multicomponent behavioral activation intervention is effective to increase the number of patients with AF to be prescribed with an ...

4. academic.oup.com academic.oup.com/eurheartj/article/45/31/2824/7702745

Atrial fibrillation burden: a new outcome predictor and ... A lower AF burden is associated with a lower risk of stroke and heart failure in patients with AF: stroke risk without anticoagulation is lower.

5. researchprotocols.org researchprotocols.org/2024/1/e51489

Developing and Validating a Self-Care Self-Efficacy Scale ... The study will involve adult outpatients with NVAF on OAC treatment for a minimum of 3 months, using both e-surveys and paper forms for data ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11263141/

Quality of Life and Safety Outcomes after First-Line Treatment ... Cryoablation, as a first-line treatment for symptomatic AF patients, significantly improved AF-specific quality of life and reduced serious adverse events.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1547527124033721

Atrial Fibrillation:Ablation Long-term health-related quality ... The study aimed to assess long-term HRQoL and rhythm data in patients with symptomatic AF. Methods. The 75 patients who underwent ablation and 74 receiving AADs ...

8. nature.com nature.com/articles/s41598-018-33531-7

Effectiveness and safety of self-managed oral ... In patients with atrial fibrillation, self-managed oral anticoagulant treatment was associated with a significantly lower risk of all-cause and ...

9. ecrjournal.com ecrjournal.com/articles/atrial-fibrillation-and-flecainide-safety-effectiveness-and-quality-life-outcomes?language_content_entity=en

Atrial Fibrillation and Flecainide - Safety, Effectiveness and ... In this study, cardioversion of AF was successful in 168 of the 376 patients within six hours. Flecainide was the most effective drug, with a primary response ...