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

NCT02627183 | Completed

• 1 other identifier: 20150742
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 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 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

Study Arms (2)

Paroxysmal AF + catheter ablation

Subjects with paroxysmal Atrial Fibrillation (AF) undergoing catheter ablation.

Procedure: Catheter ablation

Permanent/persistent AF + exercise

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).

Behavioral: Exercise training

Interventions

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).

Paroxysmal AF + catheter ablation

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).

Permanent/persistent AF + exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer L Reed, PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

• Girish Nair, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 10, 2015
• Study Start: February 16, 2016
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: May 1, 2026

Record last verified: 2023-02

Locations

CA (1)