Circulating BDNF in Patients With Atrial Fibrillation Undergoing Catheter Ablation or Exercise Training
- Conditions
- Atrial Fibrillation
- Interventions
- Procedure: Catheter ablationBehavioral: Exercise training
- Registration Number
- NCT02627183
- Lead Sponsor
- Ottawa Heart Institute Research Corporation
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Paroxysmal AF + catheter ablation Catheter ablation Subjects with paroxysmal Atrial Fibrillation (AF) undergoing catheter ablation. Permanent/persistent AF + exercise Exercise training 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).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
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 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.
Trial Locations
- Locations (1)
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada