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Circulating BDNF in Patients With Atrial Fibrillation Undergoing Catheter Ablation or Exercise Training (NEURO-AF)

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ClinicalTrials.gov Identifier: NCT02627183
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: Catheter ablation Behavioral: 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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Paroxysmal AF + catheter ablation
Subjects with paroxysmal Atrial Fibrillation (AF) undergoing catheter ablation.
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).

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
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).




Primary Outcome Measures :
  1. Changes in circulating BDNF concentrations measured by blood samples collected from subjects with atrial fibrillation [ Time Frame: 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 :
  1. Changes in subjects' symptoms measured by the patient diary for symptoms [ Time Frame: 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.

  2. Changes in depression severity measured using the Beck Depression Inventory II (BDI-II) [ Time Frame: 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.

  3. Changes in general quality of life as measured by the Short Form Health Survey 36 (SF-36) [ Time Frame: 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.

  4. Changes in disease specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS) [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Blood samples.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627183


Contacts
Contact: Jennifer L Reed, PhD 6136967392 jreed@ottawaheart.ca
Contact: Matheus E Mistura, MSc 6136967000 ext 15944 mmistura@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y4W7
Contact: Jennifer L Reed, PhD    6137985555 ext 15284    jreed@ottawaheart.ca   
Contact: Anna E Clarke, BSc    6137985555 ext 14479    aclarke@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Jennifer L Reed, PhD Ottawa Heart Institute Research Corporation
Principal Investigator: Girish Nair, MD Ottawa Heart Institute Research Corporation

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02627183     History of Changes
Other Study ID Numbers: 20150742
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by Ottawa Heart Institute Research Corporation:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes