Reversal of Atrial Substrate to Prevent Atrial

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

670 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2027-06-30

Brief Summary

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A multi-center, randomized trial to examine the effect of aggressive risk factor control and arrhythmia trigger-based intervention on recurrence of atrial fibrillation.

Detailed Description

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Atrial fibrillation (AF) is a major health problem, with a prevalence of 0.4-1% of the population. It results in high healthcare costs and significant morbidity, especially for patients with severe symptoms. Exercise and risk factor modification to prevent and modify AF has garnered a significant amount of support in cohort studies that have proven benefit. It is well known that age, body mass index, valvular heart disease, heart failure, hypertension and sleep apnea are risk factors for AF, most of which are modifiable if targeted appropriately. In addition, catheter ablation techniques have evolved and improved to reduce AF recurrence in those who are most symptomatic, and either have heart failure, or are at risk for its development. Despite these advances, the recurrence of AF remains high.

We propose to determine whether early treatment of the arrhythmogenic substrate, with or without aggressive risk factor modification, is most important in prevention of recurrent AF. It is hypothesized that patients with underlying risk factors that promote AF will benefit most from a combined strategy of aggressive risk factor modification in combination with catheter ablation.

The study design will be a two-arm, parallel group, randomized clinical trial comparing catheter ablation versus catheter ablation plus aggressive risk factor therapy, followed by maintenance with blinded endpoint evaluation. Patients with symptomatic AF and two of the following will be included: BP ≥ 140/90 or history of hypertension, BMI≥27, diabetes, prior stroke/TIA, history of heart failure (prior heart failure admission due to AF or LVEF\<40%), age≥65. Patients will be excluded if they are exercising \>150 minutes/week by self-report. Patients will be randomly allocated to one of the following groups: 1) AF ablation within 3 months, 2) AF ablation at 3 months, with a 12 week home-based exercise/risk factor management program, followed by maintenance therapy. A 5-month treatment period will be observed to deliver the interventions and have a 2 month blanking period post ablation. Guideline-directed therapy for risk factors will occur in all groups, including BP, cholesterol, diabetes, alcohol reduction and sleep apnea screening. All patients will undergo implantation of an implantable cardiac monitor (ICM) at baseline. The primary outcome will be a composite of clincally significant AF (AF ≥ 24 hours), AF-related hospitalization/emergency department visits 5 months post randomization. Secondary outcomes will include: Death, Stroke or Systemic embolism, Quality of Life, Health Outcomes, recurrent AF, \& AF burden. The sample size required is 500. Safety outcomes include: AF catheter ablation procedural complications, Anti-arrhythmic medication related adverse events, \& Death.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a parallel group, open label randomized clinical trial, with blinded endpoint evaluation (PROBE design)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aggressive Risk Factor Control

Multifaceted risk factor management relating to BP, exercise, sleep apnea, alcohol intake and diabetes management

Group Type EXPERIMENTAL

Aggressive Risk Factor Control

Intervention Type OTHER

1. Sleep apnea screening, therapy is recommended if apopnea-hypopnea (AHI) index is greater than 15, with a target index of less than 5.
2. Counseling regarding alcohol reduction to 2 drinks/day for men, 1 drink/day for women, no binge drinking (\>5 drinks at one setting).
3. Participation in a 12 week structured, home-based exercise program and nutritional counseling. Weight reduction will be emphasized through modification of diet and exercise.
4. Blood Pressure management to achieve a target systolic blood pressure (SBP) of \<120/80 mm/Hg
5. Smoking cessation facilitated through local resources already established at each site

Standard of Care

All patients in the control arm will receive therapies for AF as per the existing guidelines. BP, cholesterol, diabetic management will be administered as per the available guidelines.

Group Type ACTIVE_COMPARATOR

Standard of Care

* Permanent AF (AF lasting \> 3 years)
* Prior catheter ablation for AF
* New York Heart Association (NYHA) Class IV (Severe) heart failure,
* Participation in a cardiac rehabilitation program within the last year,
* Currently performing exercise training \>150 minutes/week of moderate to vigorous physical activity,
* Unable to exercise,
* Unable to give informed consent,
* Other noncardiovascular medical condition making 1 year survival unlikely,
* Less than 18 years of age.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Ratika Parkash

Attending Staff, Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Role: STUDY_DIRECTOR

Nova Scotia Health Authority

Identifier Type: -

Identifier Source: org_study_id

Reversal of Atrial Substrate to Prevent Atrial

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Aggressive Risk Factor Control

Aggressive Risk Factor Control

Standard of Care

Standard of Care

Interventions

Aggressive Risk Factor Control

Standard of Care

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Canadian Institutes of Health Research (CIHR)

Abbott

Phillips

Cardiac Arrhythmia Network of Canada

Nova Scotia Health Authority

Responsible Party

Ratika Parkash

Principal Investigators

Ratika Parkash

Allan Skanes

Chris Blanchard

David Birnie

George Wells

Michiel Rienstra

Jeff Healey

Jennifer Reed

Anthony Tang

Vidal Essebag

Isabelle vanGelder

John Sapp

Locations

Foothills Hospital

Mazankowski Alberta Heart Institute

Kelowna General Health

St. Paul's Hospital

Saint John Regional Hospital

QE II Health Sciences Centre

Hamilton Health Sciences Center

St. Mary's General Hospital

London Health Sciences Center

Ottawa Heart Institute

St. Michael's Hospital

Sunnybrook Health Sciences Centre

Laval Hospital

McGill University Health Centre

Montreal Heart Institute

Sacre Coeur Hospital

Regina General Hospital

Countries

Central Contacts

Ratika Parkash, MD FRCPC

Laura M Hamilton, BSc MAHSR

Facility Contacts

Stephen Wilton

Stephen Wilton, MD, FRCPC

Ken Quadros

Chris Lane

Chris Lane, MD, FRCPC

Satish Toal

Ratika Parkash

Ratika Parkash, MD MSc

Jorge Wong

Jorge Wong, MD, FRCPC

Umjeet Jolly

Umjeet Jolly, MD, FRCPC

Allan Skanes

Allan Skanes, FRCPC

David Birnie

David Birnie, MD, FRCPC

Iqwal Mangat

Iqwal Mangat, MD, FRCPC