Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT02808260 |
Other study ID # |
20160338 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 1, 2022 |
Est. completion date |
September 2034 |
Study information
Verified date |
April 2023 |
Source |
Ottawa Heart Institute Research Corporation |
Contact |
Tammy Knight |
Phone |
613-696-7000 |
Email |
tknight[@]ottawaheart.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Atrial fibrillation (AF) often starts with short episodes of rapid irregular heartbeats that
are only detected by implanted pacemakers or defibrillators. Usually people don't know that
they have these episodes. Over time, these episodes can happen more often and last for longer
periods. In some people, the heart eventually remains permanently in a fast irregular rhythm,
known as atrial fibrillation. This condition can lead to strokes and blood clots. If
physicians could detect atrial fibrillation at a very early stage they could treat people
early and possibly prevent the condition from becoming permanent. People with implanted
devices allow a unique opportunity to constantly monitor the heart rhythm so investigators
can detect any irregularities immediately.
Investigators don't know which people are at risk of developing short episodes of fast
irregular heartbeats that can lead to atrial fibrillation. The purpose of this study is to
find out if there are proteins or chemical changes in the blood that can predict the risk of
developing atrial fibrillation. These chemical changes, also known as biomarkers, may also be
able to give investigators other clues about atrial fibrillation.
Description:
Atrial fibrillation (AF) is considered to be a progressive condition that starts with
episodes of paroxysmal AF (short runs of AF), progresses to persistent AF (can be reverted to
normal rhythm) and eventually to permanent AF. More than 25% of people with paroxysmal AF
will go on to develop persistent or chronic atrial fibrillation. The progression rate is
around 5% per annum. AF can result in devastating outcomes such as stroke/TIA and systemic
embolic events. In people with implanted devices such as ICDs, investigators can detect
non-symptomatic rapid atrial arrhythmia, known as subclinical atrial fibrillation (SCAF),
before it becomes symptomatic. In the ASSERT trial, SCAF was detected in 10% of patients with
newly implanted devices within the first 3 months. Of these, nearly 16% developed clinical
atrial fibrillation within 2.5 years vs 3% in those who did not exhibit SCAF within the first
3 months. During the follow up period, a further 24.5% of patients developed SCAF. People
with SCAF also had a higher risk of stroke and systemic embolism.
Earlier diagnosis and treatment of AF may lead to better prevention and outcomes. The
availability of serum based biomarkers that can predict the early onset of atrial
fibrillation, may help in the identification of patients at risk for developing AF early.
This would also allow the identification of the patient population most suitable for the
evaluation of possible future intervention strategies to prevent the onset of atrial
fibrillation, and alter its natural history and complications.
In this study investigators will study patients that have a permanent pacemaker or
defibrillator implanted. These devices continuously monitor the patient's heart rhythm,
detecting any irregularities. Patients with these devices are followed up in outpatient
clinics on a regular basis. The information from the devices is downloaded at each follow up
visit and analyzed by staff in the clinic.
Investigators will recruit patients for this study after the device was implanted. After
obtaining consent, investigators will collect a blood sample for measuring biomarkers. They
will interview the participant in regards to previous health history, smoking, alcohol
consumption, family history and current medications. Participants' medical records will be
reviewed annually for the next 10 years, to monitor for any irregular heart rhythms,
hospitalizations and death.