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Aggressive Risk Factor Management for Atrial Fibrillation (RASTA AF Trial)

N/A

Recruiting

Led By Ratika Parkash

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Less than 18 years of age

New York Heart Association (NYHA) Class IV (Severe) heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether controlling risk factors and intervening when arrhythmias are triggered can reduce the recurrence of atrial fibrillation.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects from interventions may include discomfort from lifestyle changes such as diet and exercise adjustments required for aggressive risk factor control. Standard care treatments' side effects depend on the specific procedures and medications used.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have severe heart failure.

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I am unable to understand and agree to the study's details on my own.

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I have a health condition that may not let me live beyond a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of AF related Emergency Department (ED) visits post ablation

Number of AF related hospitalizations post ablation

Number of clinically significant AF events post ablation

Secondary study objectives

AF at any time

All-cause mortality

Association between gender, AF risk factors and aggressive risk factor management

+11 more

Other study objectives

Death (Safety)

Number of ablation procedural complications [Safety]

Number of antiarrhythmic drug adverse effects [Safety]

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met