Rate Control Self-adjustment in Patients With Permanent or Persistent Atrial Fibrillation Using Device Home Monitoring

NCT05066971 | Unknown

• 1 other identifier: 2019-2913
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with permanent or persistent atrial fibrillation require rate control medication to prevent excessive tachycardia. Since too much medication leads to a lower than expected heart rate (low output and symptoms) and too little leads to a fast heart rate (with associated symptoms), finding the ideal medication level (target that could fluctuate) is vital for patient's wellbeing. Clinicians adjust the medication each time patients come into the clinic (once or twice a year). In between those visits, medication is not changed even though patients would benefit for some incremental medication adjustment. Patients implanted with Biotronik devices have access to Home Monitoring® (HM), a user friendly remote monitoring system transmitting daily device and patient information to clinicians. Heart rate and activity hours can be tracked and this information could be used to adjust medication. In a step by step process, patients will gradually gain autonomy in the weekly adjustment of their rate control medication. In order to guide medication adjustment by patients, the research team will filter and simplify the information received by HM before sending it to patients. It is hypothesize that patient empowerment, understanding the dynamics of their heart rates in relation to the amount of medication used, will lead to better heart rate control, and it will improve the daily hours of patients activity.

Conditions

Atrial Fibrillation, Persistent

Keywords

Atrial fibrillation; Patient empowerment; Personalized medicine; Rate control

Outcome Measures

Primary Outcomes (3)

• 6 minutes walk test

  Difference in meters walked between first and last 6 minutes walk test

  Baseline, end of the study (12 months after first 6 minute walk test)

• Heart rate control target

  Number of weeks where the heart rate is between 80 and 110 beats per minute

  Through study completion, up to 1 year

• Physical activity during the day

  Percentage of physical activity during the day measured by the pacemaker accelerometer at the end of each week

  Through study completion, up to 1 year

Study Arms (1)

Participants in gradual self-adjustment rate control medication

EXPERIMENTAL

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.

Combination Product: Self-adjustment of medication

Interventions

Self-adjustment of medication COMBINATION_PRODUCT

Each week, based on the information provided by HM (heart rate and hours of activity each day), the rate control medication is adjusted to increase the total of activity time.

Participants in gradual self-adjustment rate control medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with persistent or permanent atrial fibrillation, on rate control medication stable for at least 6 months
• patients with a Biotronik pacemaker connected to HM system

You may not qualify if:

• patients with heart failure in need of maximum beta blocker titration
• patients with other indications that would prevent medication adjustment

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

CHUS Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (4)

• Van Gelder IC, Groenveld HF, Crijns HJ, Tuininga YS, Tijssen JG, Alings AM, Hillege HL, Bergsma-Kadijk JA, Cornel JH, Kamp O, Tukkie R, Bosker HA, Van Veldhuisen DJ, Van den Berg MP; RACE II Investigators. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med. 2010 Apr 15;362(15):1363-73. doi: 10.1056/NEJMoa1001337. Epub 2010 Mar 15.

  PMID: 20231232 BACKGROUND

• Yee R, Verma A, Beardsall M, Fraser J, Philippon F, Exner DV. Canadian Cardiovascular Society/Canadian Heart Rhythm Society joint position statement on the use of remote monitoring for cardiovascular implantable electronic device follow-up. Can J Cardiol. 2013 Jun;29(6):644-51. doi: 10.1016/j.cjca.2012.11.036. Epub 2013 Mar 5.

  PMID: 23465345 BACKGROUND

• Chronaki CE, Vardas P. Remote monitoring costs, benefits, and reimbursement: a European perspective. Europace. 2013 Jun;15 Suppl 1:i59-i64. doi: 10.1093/europace/eut110.

  PMID: 23737233 BACKGROUND

• Slotwiner D, Varma N, Akar JG, Annas G, Beardsall M, Fogel RI, Galizio NO, Glotzer TV, Leahy RA, Love CJ, McLean RC, Mittal S, Morichelli L, Patton KK, Raitt MH, Ricci RP, Rickard J, Schoenfeld MH, Serwer GA, Shea J, Varosy P, Verma A, Yu CM. HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. Heart Rhythm. 2015 Jul;12(7):e69-100. doi: 10.1016/j.hrthm.2015.05.008. Epub 2015 May 14. No abstract available.

  PMID: 25981148 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Patient Participation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Felix Alejandro Ayala Paredes, MD PhD

  Sherbrooke university medical school

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Alejandro Ayala Paredes, MD PhD

CONTACT

+1 819 3461110; felix.ayala-paredes@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, electrophysiologist

Model Details: All participants follow the same intervention

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: October 4, 2021
• Study Start: July 1, 2022
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2025
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)