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

May 25, 2022 updated by: Félix Ayala-Paredes, Université de Sherbrooke

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS Fleurimont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants in gradual self-adjustment rate control medication
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minutes walk test
Time Frame: Baseline, end of the study (12 months after first 6 minute 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
Time Frame: Through study completion, up to 1 year
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
Time Frame: Through study completion, up to 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Felix Alejandro Ayala Paredes, MD PhD, Sherbrooke university medical school

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

June 15, 2024

Study Completion (Anticipated)

June 15, 2025

Study Registration Dates

First Submitted

June 12, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-2913

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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