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

NCT ID: NCT02627183

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Paroxysmal AF + catheter ablation

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

Catheter ablation

Intervention Type PROCEDURE

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

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).

Exercise training

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type PROCEDURE

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jennifer L Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Girish Nair, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jennifer L Reed, PhD

Role: CONTACT

6136967392

Matheus E Mistura, MSc

Role: CONTACT

6136967000 ext. 15944

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jennifer L Reed, PhD

Role: primary

6137985555 ext. 15284

Anna E Clarke, BSc

Role: backup

6137985555 ext. 14479

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20150742

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RF Ablation of Atrial Fibrillation
NCT00265629 COMPLETED PHASE1
Specific Electrophenotypes in Atrial Fibrillation
NCT05366530 ACTIVE_NOT_RECRUITING