Clinical trial NCT02627183: Circulating BDNF in Patients With Atrial Fibrillation Undergoing Catheter Ablation or Exercise Training
Official title: Circulating Brain-derived Neurotrophic Factor (BDNF) in Patients With Atrial Fibrillation Undergoing Catheter Ablation or Exercise Training: A Pilot Study (NEURO-AF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in circulating BDNF concentrations measured by blood samples collected from subjects with atrial fibrillation
timeFrame: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Secondary outcomes:
measure: Changes in subjects' symptoms measured by the patient diary for symptoms
timeFrame: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
measure: Changes in depression severity measured using the Beck Depression Inventory II (BDI-II)
timeFrame: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
measure: Changes in general quality of life as measured by the Short Form Health Survey 36 (SF-36)
timeFrame: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
measure: Changes in disease specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
timeFrame: approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Jennifer L Reed, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Girish Nair, MD
role: PRINCIPAL_INVESTIGATOR
References: