Atrial FibrillationNEURO-AFNCT02627183
Circulating BDNF in Patients With Atrial Fibrillation Undergoing Catheter Ablation or Exercise Training
An observational study of Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
The main purpose of this project is to determine the impact of atrial fibrillation interventions (catheter ablation and exercise training) on circulating BDNF concentrations in patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter ablation and Exercise training
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 16 Feb 2016to 13 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with paroxysmal atrial fibrillation that will undergo catheter ablation and subjects with permanent or persistent atrial fibrillation undergoing exercise training two times weekly for 12 weeks as part of their involvement in the OPPORTUNITY Study (NCT02602457).
Who may be able to join
- Subjects must be either currently enrolled in the OPPORTUNITY trial (NCT02602457) or have paroxysmal atrial fibrillation and be scheduled to undergo catheter ablation (for the first time) through the electrophysiology clinic at the University of Ottawa Heart Institute.
- Subjects must be willing and able to provide a blood sample.
- Subjects must be willing and able to provide informed consent.
Who cannot join
- Subject is not either currently enrolled in the OPPORTUNITY trial (NCT02602457) or scheduled to undergo catheter ablation (for the first time) through the electrophysiology clinic at the University of Ottawa Heart Institute for paroxysmal atrial fibrillation.
- Subjects with congestive heart failure with heart failure admission in the past 3 months.
- Subjects with a cerebrovascular accident in the past 3 months
- Subjects with severe dementia.
- Subjects with a history of severe psychiatric illness (e.g., schizoaffective disorder, bipolar disorder, or schizophrenia).
- Subjects with an active infection or inflammatory condition.
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- Subjects who are pregnant, lactating or planning to become pregnant during the study period.
- Subject is unable to read or understand English or French.
- Subject is unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulating Brain-derived Neurotrophic Factor (BDNF) in Patients With Atrial Fibrillation Undergoing Catheter Ablation or Exercise Training: A Pilot Study (NEURO-AF)
The main purpose of this project is to determine the impact of atrial fibrillation interventions (catheter ablation and exercise training) on circulating BDNF concentrations in patients with atrial fibrillation. It also seeks to determine if there is a relation between circulating BDNF concentrations and mental health (depression severity, quality of life and symptoms) among those undergoing interventions for atrial fibrillation catheter ablation or exercise training.
Read the detailed description
The main purpose of this project is to determine the impact of atrial fibrillation interventions (catheter ablation and exercise training) on circulating BDNF concentrations in patients with atrial fibrillation. It also seeks to determine if there is a relation between circulating BDNF concentrations and mental health (depression severity, quality of life and symptoms) among those undergoing interventions for atrial fibrillation catheter ablation or exercise training. Using a pre-post study design, the investigators will explore interventions in two subsets of patients at the opposite end of the atrial fibrillation clinical spectrum. Arm 1: patients with paroxysmal atrial fibrillation will undergo catheter ablation (n=100). Arm 2: patients with permanent or persistent atrial fibrillation will perform exercise training 2 times weekly for 12 weeks (n=100). Total sample size will be 200 participants. All measurements will be performed at baseline and follow-up.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter ablation, Exercise training
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Subjects undergoing catheter ablation for the first time for atrial fibrillation as part of their regular care (regardless of involvement in this study).
Exercise trainingBehavioural
Subjects participating in supervised exercise classes for up to 60 minutes in length 2 times/week as part of their involvement in another study (NCT02602457).
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal AF + catheter ablation | Subjects with paroxysmal Atrial Fibrillation (AF) undergoing catheter ablation. Receives: Procedure: Catheter ablation | |
| Permanent/persistent AF + exercise | Subjects with permanent or persistent Atrial Fibrillation (AF) undergoing exercise training two times weekly for 12 weeks as part of their involvement in the OPPORTUNITY Study (NCT02602457). Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in circulating BDNF concentrations measured by blood samples collected from subjects with atrial fibrillation
Changes in circulating BDNF concentrations measured by blood samples collected from subjects with atrial fibrillation approximately 3 months post catheter ablation or following the 12 week exercise training intervention.
Measured: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Secondary outcomes (4)
Changes in subjects' symptoms measured by the patient diary for symptoms
Changes in subjects' symptoms measured by the patient diary for symptoms approximately 3 months post catheter ablation or following the 12 week exercise training intervention period.
Measured: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Changes in depression severity measured using the Beck Depression Inventory II (BDI-II)
Changes in depression severity measured using the Beck Depression Inventory II (BDI-II) approximately 3 months after catheter ablation or following the 12 week exercise training intervention period.
Measured: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Changes in general quality of life as measured by the Short Form Health Survey 36 (SF-36)
Changes in general quality of life as measured by the Short Form Health Survey 36 (SF-36) approximately 3 months after catheter ablation or following the 12 week exercise training intervention period.
Measured: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Changes in disease specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
Changes in disease specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS) approximately 3 months after catheter ablation or following the 12 week exercise training intervention period.
Measured: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start16 Feb 2016
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer L Reed, PhD, Principal investigator, Ottawa Heart Institute Research CorporationGirish Nair, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627183
- Sponsor's protocol ID
- 20150742
- Acronym
- NEURO-AF
- Status last verified
- Feb 2023
- First submitted
- 8 Dec 2015
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Brain-derived Neurotrophic Factor (BDNF) in Patients With Atrial Fibrillation Undergoing Catheter Ablation or Exercise Training: A Pilot Study (NEURO-AF)
- ClinicalTrials.gov ID
- NCT02627183
- Acronym / sponsor ID
- NEURO-AF / 20150742
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this project is to determine the impact of atrial fibrillation interventions (catheter ablation and exercise training) on circulating BDNF concentrations in patients with atrial fibrillation. It also seeks to determine if there is a relation between circulating BDNF concentrations and mental health (depression severity, quality of life and symptoms) among those undergoing interventions for atrial fibrillation catheter ablation or exercise training.
Detailed description
The main purpose of this project is to determine the impact of atrial fibrillation interventions (catheter ablation and exercise training) on circulating BDNF concentrations in patients with atrial fibrillation. It also seeks to determine if there is a relation between circulating BDNF concentrations and mental health (depression severity, quality of life and symptoms) among those undergoing interventions for atrial fibrillation catheter ablation or exercise training. Using a pre-post study design, the investigators will explore interventions in two subsets of patients at the opposite end of the atrial fibrillation clinical spectrum. Arm 1: patients with paroxysmal atrial fibrillation will undergo catheter ablation (n=100). Arm 2: patients with permanent or persistent atrial fibrillation will perform exercise training 2 times weekly for 12 weeks (n=100). Total sample size will be 200 participants. All measurements will be performed at baseline and follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal AF + catheter ablation | – | Procedure: Catheter ablationSubjects with paroxysmal Atrial Fibrillation (AF) undergoing catheter ablation. |
| Permanent/persistent AF + exercise | – | Behavioral: Exercise trainingSubjects with permanent or persistent Atrial Fibrillation (AF) undergoing exercise training two times weekly for 12 weeks as part of their involvement in the OPPORTUNITY Study (NCT02602457). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with paroxysmal atrial fibrillation that will undergo catheter ablation and subjects with permanent or persistent atrial fibrillation undergoing exercise training two times weekly for 12 weeks as part of their involvement in the OPPORTUNITY Study (NCT02602457).
Key inclusion criteria (3 listed)
- Subjects must be either currently enrolled in the OPPORTUNITY trial (NCT02602457) or have paroxysmal atrial fibrillation and be scheduled to undergo catheter ablation (for the first time) through the electrophysiology clinic at the University of Ottawa Heart Institute.
- Subjects must be willing and able to provide a blood sample.
- Subjects must be willing and able to provide informed consent.
Key exclusion criteria (9 listed)
- Subject is not either currently enrolled in the OPPORTUNITY trial (NCT02602457) or scheduled to undergo catheter ablation (for the first time) through the electrophysiology clinic at the University of Ottawa Heart Institute for paroxysmal atrial fibrillation.
- Subjects with congestive heart failure with heart failure admission in the past 3 months.
- Subjects with a cerebrovascular accident in the past 3 months
- Subjects with severe dementia.
- Subjects with a history of severe psychiatric illness (e.g., schizoaffective disorder, bipolar disorder, or schizophrenia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablationSubjects undergoing catheter ablation for the first time for atrial fibrillation as part of their regular care (regardless of involvement in this study). | Procedure or surgery | Paroxysmal AF + catheter ablation |
| Exercise trainingSubjects participating in supervised exercise classes for up to 60 minutes in length 2 times/week as part of their involvement in another study (NCT02602457). | Behavioural | Permanent/persistent AF + exercise |
Primary outcome
Changes in circulating BDNF concentrations measured by blood samples collected from subjects with atrial fibrillation
Time frame: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Changes in circulating BDNF concentrations measured by blood samples collected from subjects with atrial fibrillation approximately 3 months post catheter ablation or following the 12 week exercise training intervention.
4 secondary outcomes
Changes in subjects' symptoms measured by the patient diary for symptoms
Time frame: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Changes in depression severity measured using the Beck Depression Inventory II (BDI-II)
Time frame: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Changes in general quality of life as measured by the Short Form Health Survey 36 (SF-36)
Time frame: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Changes in disease specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
Time frame: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Reed, PhD principal investigator
Ottawa Heart Institute Research Corporation
Girish Nair, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in circulating BDNF concentrations measured by blood samples collected from subjects with atrial fibrillation (time frame: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.