Circulating BDNF in Patients With Atrial Fibrillation Undergoing Catheter Ablation or Exercise Training

Circulating Brain-derived Neurotrophic Factor (BDNF) in Patients With Atrial Fibrillation Undergoing Catheter Ablation or Exercise Training: A Pilot Study (NEURO-AF)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02627183

Acronym

NEURO-AF

Enrollment

200

Registered

2015-12-10

Start date

2016-02-16

Completion date

2024-06-13

Last updated

2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Brief summary

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.

Interventions

PROCEDURECatheter ablation

Subjects undergoing catheter ablation for the first time for atrial fibrillation as part of their regular care (regardless of involvement in this study).

BEHAVIORALExercise training

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 design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 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. 2. Subjects must be willing and able to provide a blood sample. 3. Subjects must be willing and able to provide informed consent.

Exclusion criteria

1. 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. 2. Subjects with congestive heart failure with heart failure admission in the past 3 months. 3. Subjects with a cerebrovascular accident in the past 3 months 4. Subjects with severe dementia. 5. Subjects with a history of severe psychiatric illness (e.g., schizoaffective disorder, bipolar disorder, or schizophrenia). 6. Subjects with an active infection or inflammatory condition. 7. Subjects who are pregnant, lactating or planning to become pregnant during the study period. 8. Subject is unable to read or understand English or French. 9. Subject is unable to provide informed consent.

Design outcomes

Primary

Measure	Time frame	Description
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 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.

Secondary

Measure	Time frame	Description
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	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.
Changes in depression severity measured using the Beck Depression Inventory II (BDI-II)	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) approximately 3 months after 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)	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) approximately 3 months after 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)	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) approximately 3 months after catheter ablation or following the 12 week exercise training intervention period.

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORJennifer L Reed, PhD

Ottawa Heart Institute Research Corporation

PRINCIPAL_INVESTIGATORGirish Nair, MD