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

Atrial Fibrillation Clinical Trial

— NEURO-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02627183
• Other study ID #: 20150742
• Status: Recruiting
• Start date: December 2015
• Est. completion date: January 2024

Study information

• Verified date: February 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: Jennifer L Reed, PhD
• Phone: 6136967392
• Email: jreed[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Behavioral:
• Exercise 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).

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Secondary	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.	approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Secondary	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.	approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Secondary	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.	approximately 3 months post catheter ablation or following the 12 week exercise training intervention period
Secondary	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.	approximately 3 months post catheter ablation or following the 12 week exercise training intervention period