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Completed

NCT Number: NCT02627183

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Catheter ablation

Procedure

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

Exercise Training

Behavioral

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 subjects' symptoms measured by the patient diary for symptoms approximately 3 months post catheter ablation or following the 12 week exercise training intervention period.

  2. 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 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.

  3. 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 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.

  4. 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

    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.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

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

Acronym: NEURO-AF

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2015
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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