Super-Rehab: a Novel Approach to Reverse Atrial Fibrillation — SuRe-AF  

Atrial Fibrillation Clinical Trial

Official title: "Super Rehab": A Novel Approach to Reverse Atrial Fibrillation (a Randomised Controlled Trial)

Status Recruiting

Clinical Trial Summary

The "Super Rehab: a novel approach to reverse atrial fibrillation?" study proposes to test the use of a novel lifestyle intervention (Super Rehab), in addition to standard care, for patients with symptomatic atrial fibrillation (AF) requiring rhythm control strategy who are overweight.

As the main driver behind the selection of a rhythm-control strategy for patients with AF, the primary outcome will be an improvement in AF-related symptoms with Super Rehab versus Usual Care only. Key secondary outcomes will include the burden of AF, change in stroke risk, biochemical and cardiac functional and structural changes, and markers of quality-of-life and health economic costs.

Clinical Trial Description

In this randomised controlled trial (RCT) the investigators will study the efficacy of a novel lifestyle intervention (Super Rehab), in addition to usual care, for patients with symptomatic atrial fibrillation (AF) where are a rhythm-control strategy is being employed who are overweight. Increasing evidence has shown that AF can respond to robust lifestyle change and aggressive risk factor modification, and in some case can in fact regress.

In the majority of cases, the decision to target a rhythm-control strategy for AF is based on the symptom-burden reported by the patient. This in light of the low volume of evidence suggesting any benefits of rhythm-control strategies over rate-control strategies based on prognostic clinical outcomes.

The modifiable cardiovascular (CV) risk factors that increase both CV risk and the frequency of its various forms of disease also impact the development and progression of AF. In addition, patients with multiple CV risk factors are at enhanced risk of both poorer long-term outcomes and earlier failures of traditional rhythm-control strategies.

This RCT study will involve patients who have described symptomatic AF such that their treating team have elected a rhythm-control strategy (i.e. a combination of anti-arrhythmic therapy ± a referral for a direct current (DC) cardioversion and/or an ablation) who are also overweight (body mass index [BMI] ≥27kg/m2). The BMI criterion acts as a marker of CV risk that may respond to a lifestyle intervention, which has proved sensitive in other studies.

Participants will be randomised to either Super Rehab and Usual Care or to continue Usual Care only. Super Rehab includes a combination of 1:1 supervised high-intensity exercise, dietary advice sessions and 3-monthly clinical reviews to optimise CV risk factor management. The whole programme lasts 12 months. Participants in both arms will undergo imaging, fitness, clinical tests (including blood tests), and complete questionnaires on four occasions during the study.

The primary outcome of the study will assess the difference in AF symptom burden between the two groups. In addition, the study will assess important secondary outcomes that include change in AF burden (i.e. the amount of time spent in AF), stroke risk, quality-of-life and well-being, biochemical, anthropometric, blood pressure and cardiac functional and structural changes, and a cost-effectiveness analysis. ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Overweight
• Overweight and Obesity

• NCT number: NCT05596175
• Study type: Interventional
• Source: Royal United Hospitals Bath NHS Foundation Trust
• Contact: John Graby
• Phone: 01225 824160
• Email: john.graby@nhs.net
• Status: Recruiting
• Phase: Phase 3
• Start date: April 3, 2023
• Completion date: July 31, 2025