Aggressive Risk Factor Management for Atrial Fibrillation
(RASTA AF Trial)
Recruiting in Palo Alto (17 mi)
+15 other locations
Overseen byRatika Parkash
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nova Scotia Health Authority
Disqualifiers: Permanent AF, Prior ablation, NYHA IV, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
A multi-center, randomized trial to examine the effect of aggressive risk factor control and arrhythmia trigger-based intervention on recurrence of atrial fibrillation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Aggressive Risk Factor Management for Atrial Fibrillation?
Research shows that managing lifestyle and risk factors can improve outcomes for people with atrial fibrillation (AF). Effective lifestyle management can help stop and even reverse the progression of AF, and it increases the chances of staying free from irregular heartbeats after certain procedures.12345
Is aggressive risk factor management for atrial fibrillation safe for humans?
How does the Aggressive Risk Factor Management treatment for atrial fibrillation differ from other treatments?
Aggressive Risk Factor Management for atrial fibrillation is unique because it focuses on modifying lifestyle and managing risk factors like obesity, sleep apnea, and high cholesterol, rather than just using medication or procedures. This comprehensive approach aims to reduce symptoms and improve outcomes by addressing the root causes of the condition.13489
Eligibility Criteria
This trial is for adults with symptomatic atrial fibrillation who haven't improved with rate control and have at least two risk factors like obesity, high blood pressure, prior stroke or diabetes. They should want catheter ablation but can't be in severe heart failure, under 18, have a very large left atrium, unable to consent or exercise, already exercising a lot or have another serious illness.Inclusion Criteria
I have atrial fibrillation with symptoms, want catheter ablation, and meet at least two other health criteria.
Exclusion Criteria
You are not able to do physical activities.
I am under 18 years old.
Your left atrial size is larger than 5.5 centimeters.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo catheter ablation and/or aggressive risk factor management for atrial fibrillation
5 months
Multiple visits for ablation and risk factor management
Blinding Period
A 2-month blanking period post-ablation to stabilize treatment effects
2 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including AF events and quality of life assessments
Up to 72 months
Treatment Details
Interventions
- Aggressive Risk Factor Control (Other)
- Standard of Care (Other)
Trial OverviewThe study compares aggressive risk factor management (like improving blood pressure and weight) plus standard care against standard care alone in preventing the return of atrial fibrillation after treatment. Participants are randomly assigned to one of these approaches.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Aggressive Risk Factor ControlExperimental Treatment1 Intervention
Multifaceted risk factor management relating to BP, exercise, sleep apnea, alcohol intake and diabetes management
Group II: Standard of CareActive Control1 Intervention
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.
Aggressive Risk Factor Control is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Aggressive Risk Factor Control for:
- Prevention of Atrial Fibrillation Recurrence
- Cardiovascular Disease Prevention
🇺🇸 Approved in United States as Aggressive Risk Factor Control for:
- Atrial Fibrillation Management
- Cardiovascular Risk Reduction
🇨🇦 Approved in Canada as Aggressive Risk Factor Control for:
- Prevention of Atrial Fibrillation
- Cardiovascular Health
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Foothills HospitalCalgary, Canada
Mazankowski Alberta Heart InstituteEdmonton, Canada
Kelowna General HealthKelowna, Canada
St. Paul's HospitalVancouver, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Nova Scotia Health AuthorityLead Sponsor
PhillipsCollaborator
Cardiac Arrhythmia Network of CanadaCollaborator
Canadian Institutes of Health Research (CIHR)Collaborator
AbbottIndustry Sponsor
Ottawa Heart Institute Research CorporationCollaborator
References
Lifestyle Modification and Atrial Fibrillation: Critical Care for Successful Ablation. [2022]Management of atrial fibrillation (AF) requires a comprehensive approach due to the limited success of medical or procedural approaches in isolation. Multiple modifiable risk factors contribute to the development and progression of the underlying substrate, with a heightened risk of progression evident with inadequate risk factor management. With increased mortality, stroke, heart failure and healthcare utilisation linked to AF, international guidelines now strongly support risk factor modification as a critical pillar of AF care due to evidence demonstrating the efficacy of this approach. Effective lifestyle management is key to arrest and reverse the progression of AF, in addition to increasing the likelihood of freedom from arrhythmia following catheter ablation.
Prevalence of modifiable risk factors and relation to stroke and death in patients with atrial fibrillation: A report from the China atrial fibrillation registry study. [2020]Lifestyle and risk factor management may improve outcomes in patients with atrial fibrillation (AF). We aim to evaluate the prevalence of modifiable risk factors and how these factors impact clinical outcomes in patients with AF.
Comparing the guidelines: anticoagulation therapy to optimize stroke prevention in patients with atrial fibrillation. [2013]Atrial fibrillation (AF) is an important risk factor for stroke. According to a pooled analysis of controlled clinical trials with warfarin, anticoagulation therapy reduces stroke risk by 62%. However, clinicians must decide whether the benefit of long-term anticoagulation therapy with available agents outweighs the risk of bleeding for individual patients. Guidelines issued by the American College of Chest Physicians and by the joint American College of Cardiology, American Heart Association, and the European Society of Cardiology task force recommend antithrombotic therapy to protect AF patients from stroke based on risk-stratification algorithms. Risk factors for stroke AF patients include age > or =75 years; hypertension; thyrotoxicosis; diabetes; cardiovascular disease; congestive heart failure; and history of stroke, transient ischemic attack, or thromboembolism. Patients at high risk for stroke experience greater absolute benefit from anticoagulation therapy than patients at low risk. The guidelines are consistent in recommendations for high-risk patients (warfarin therapy, international normalized ratio 2.0 to 3.0) and low-risk patients (aspirin 325 mg), but differ for intermediate-risk patients with diabetes or heart disease. The guidelines continue to evolve, and future guidelines are likely to incorporate new clinical data, including the CHADS(2) algorithm for determining risk and the results of the Atrial Fibrillation Follow-up Investigation of Rhythm Management trial, the Rate Control versus Electrical Cardioversion for Persistent Atrial Fibrillation study, and the Stroke Prevention Using an Oral Thrombin Inhibitor in Atrial Fibrillation II to V trials.
Occurrence and characteristics of stroke events in the Atrial Fibrillation Follow-up Investigation of Sinus Rhythm Management (AFFIRM) study. [2022]Atrial fibrillation (AF) is a risk factor for stroke, especially when accompanied by other high-risk cardiovascular predictors. The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Study was a multicenter comparison of high-risk patients with AF who were randomized to either a sinus rhythm control or a rate control strategy.
Improving outcomes in patients with atrial fibrillation: rationale and design of the Early treatment of Atrial fibrillation for Stroke prevention Trial. [2013]Even on optimal therapy including anticoagulation and rate control, major cardiovascular complications (stroke, cardiovascular death, and acute heart failure) are common in patients with atrial fibrillation (AF). Conceptually, maintenance of sinus rhythm could prevent adverse outcomes related to AF. Rhythm control therapy has been only moderately effective in published trials, and its potential benefit was offset by side effects of repeated interventions.
Four-year incidence of major adverse cardiovascular events in patients with atherosclerosis and atrial fibrillation. [2021]There is a paucity of contemporary data assessing the implications of atrial fibrillation (AF) on major adverse cardiovascular events (MACE) in patients with or at high-risk for atherosclerotic disease managed in routine practice.
Association of pulmonary vein isolation and major cardiovascular events in patients with atrial fibrillation. [2022]Patients with atrial fibrillation (AF) face an increased risk of adverse cardiovascular events. Evidence suggests that early rhythm control including AF ablation may reduce this risk.
Lifestyle modifications for treatment of atrial fibrillation. [2020]The management of atrial fibrillation (AF) has focused on anticoagulation, rhythm control and ventricular rate control. Recently, a fourth pillar of AF management has been incorporated recognising the importance of risk factor management (RFM). There are several risk factors that contribute to the development and progression of AF, these include traditional risk factors such as age, hypertension, heart failure, diabetes and valvular heart disease. However, increasingly it is recognised that obesity, sleep apnoea, hyperlipidaemia, smoking, alcohol, physical inactivity, genetics, aortic stiffness are associated with the development of AF. Importantly, several of these risk factors are modifiable. We have seen the evolution of RFM programmes which have demonstrated promising results. Indeed, the evidence is now so compelling that major clinical guidelines strongly advocate that aggressive treatment of these risk factors as a key component of AF management. Patients with AF who comprehensively managed their risk factors demonstrate greater reduction in symptoms, AF burden, more successful ablations and improved outcomes with greater AF freedom. In this article, we will review the evidence for the association between cardiac risk factors and AF and assess the burgeoning evidence for improved AF outcomes associated with aggressive cardiac RFM.
Obesity, Exercise, Obstructive Sleep Apnea, and Modifiable Atherosclerotic Cardiovascular Disease Risk Factors in Atrial Fibrillation. [2022]Classically, the 3 pillars of atrial fibrillation (AF) management have included anticoagulation for prevention of thromboembolism, rhythm control, and rate control. In both prevention and management of AF, a growing body of evidence supports an increased role for comprehensive cardiac risk factor modification (RFM), herein defined as management of traditional modifiable cardiac risk factors, weight loss, and exercise. In this narrative review, we summarize the evidence demonstrating the importance of each facet of RFM in AF prevention and therapy. Additionally, we review emerging data on the importance of weight loss and cardiovascular exercise in prevention and management of AF.