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

Primary Purpose

Atrial Fibrillation, Persistent

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Self-adjustment of medication
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atrial Fibrillation, Persistent focused on measuring Atrial fibrillation, Patient empowerment, Personalized medicine, Rate control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • CHUS Fleurimont

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants in gradual self-adjustment rate control medication

Arm Description

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.

Outcomes

Primary Outcome Measures

6 minutes walk test
Difference in meters walked between first and last 6 minutes walk test
Heart rate control target
Number of weeks where the heart rate is between 80 and 110 beats per minute
Physical activity during the day
Percentage of physical activity during the day measured by the pacemaker accelerometer at the end of each week

Secondary Outcome Measures

Full Information

First Posted
June 12, 2021
Last Updated
May 25, 2022
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT05066971
Brief Title
Rate Control Self-adjustment in Patients With Permanent or Persistent Atrial Fibrillation Using Device Home Monitoring
Official Title
Personalized Medicine: Home Monitoring as a Tool to Patient Empowerment. Rate Control Self-adjustment in Patients With Permanent or Persistent Atrial Fibrillation Using Cardiovascular Implantable Electronic Device (CIED) Information
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients with permanent or persistent atrial fibrillation require rate control medication to prevent heart rate (HR) speed up. Beta-blockers or calcium channel blockers are used to achieve a reasonable HR; symptoms, EKG and Holter recordings guide clinicians to rate control targets at clinical encounters (at our pacemaker clinic at 6 to 12 months intervals). Once a target HR is achieved, unless new symptoms arise, medication is seldom modified. Rate control medications need to be well adjusted: if not enough dose administered, HR will increase, leading to palpitations, shortness of breath and eventually heart failure; if too much medication is given, patients would experience low cardiac output symptoms (fatigue, tiredness, shortness of breath, low blood pressure, and eventually syncope). Clinicians tend to over control heart rates with no added benefits. Most of patients with a pacemaker or defibrillator at our center are offered a remote monitoring system as part of a regular follow up schema at our pacemaker clinic; usually to reduce in face encounters, and to be alerted if a problem arises with the pacemaker or defibrillator. There are many remote monitoring systems (five, one for each vendor implanted at our center), and the Home Monitoring® (HM) from Biotronik is specially friendly as all information from the device (pacemaker or defibrillator) is transmitted every day to our clinic with no interaction from the patient side. Beside device status itself (remaining battery, system integrity) daily mean heart rates (measured in beats per minute: bpm) and patient activity (measured as hours per day in activity, as detected by the movement or activity sensor implanted in the device) are also transmitted, but if HR are between safety boundaries (programmed for each patient after implant), all information is rarely used for any other purpose. If patients with permanent or persistent atrial fibrillation, rate control stable medication, and a HM pacemaker, are followed closely (every week) to adjust the medication (every week if needed, by the research team at the beginning) based on mean heart rates and daily activities already received, we hypothesize that patients will achieve not only better rate control targets, but they will increase their hours of activity per day. Eventually once the patient has understood the principle, medication adjustment would be done by the patient itself based on the same simple information redirected to him or her.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Persistent
Keywords
Atrial fibrillation, Patient empowerment, Personalized medicine, Rate control

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants follow the same intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants in gradual self-adjustment rate control medication
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Self-adjustment of medication
Intervention Description
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.
Primary Outcome Measure Information:
Title
6 minutes walk test
Description
Difference in meters walked between first and last 6 minutes walk test
Time Frame
Baseline, end of the study (12 months after first 6 minute walk test)
Title
Heart rate control target
Description
Number of weeks where the heart rate is between 80 and 110 beats per minute
Time Frame
Through study completion, up to 1 year
Title
Physical activity during the day
Description
Percentage of physical activity during the day measured by the pacemaker accelerometer at the end of each week
Time Frame
Through study completion, up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: patients with heart failure in need of maximum beta blocker titration patients with other indications that would prevent medication adjustment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felix Alejandro Ayala Paredes, MD PhD
Phone
+1 819 3461110
Ext
74947
Email
felix.ayala-paredes@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Alejandro Ayala Paredes, MD PhD
Organizational Affiliation
Sherbrooke university medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUS Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20231232
Citation
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.
Results Reference
background
PubMed Identifier
23465345
Citation
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.
Results Reference
background
PubMed Identifier
23737233
Citation
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.
Results Reference
background
PubMed Identifier
25981148
Citation
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.
Results Reference
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Rate Control Self-adjustment in Patients With Permanent or Persistent Atrial Fibrillation Using Device Home Monitoring

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