Super-Rehab: a Novel Approach to Treat Atrial Fibrillation (SuRe-AF)

Royal United Hospitals Bath NHS Foundation Trust

Status: Active, not recruiting

Conditions: Atrial Fibrillation; Overweight and Obesity

Treatments: Behavioral: Super Rehab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05596175

RUH Bath NHS SR AF

Details and patient eligibility

About

This study proposes to evaluate the effectiveness 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. Secondary outcomes will include the burden of AF, biochemical and cardiac functional and structural changes, and markers of quality-of-life and health resource use.

Full 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 for 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), quality-of-life and well-being, biochemical, anthropometric, blood pressure and cardiac functional and structural changes.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged >18
• Symptomatic AF (paroxysmal or persistent <12-months) with a rhythm control management strategy selected including consideration of referral for a cardioversion or ablation forming part of their planned pathway
• BMI ≥27m/kg2

Exclusion criteria

• Prognostic coronary artery disease, defined as left main stem >50% stenosis and/or ≥ moderate disease in ≥3 major epicardial vessels requiring revascularisation.
• Unstable angina
• New York Heart Association class III/IV heart failure or severe left ventricular impairment
• Significant cardiomyopathy (as assessed by Cardiologist, e.g. hypertrophic cardiomyopathy or arrhythmogenic right ventricular cardiomyopathy)
• Severe heart valve disease
• Severe hypertension (BP >180/120mmHg) despite optimising anti-hypertensive therapy
• Uncontrolled arrhythmia or higher degree heart block
• History of aortic dissection
• Recent acute pulmonary embolus, deep vein thrombosis, stroke or transient ischaemic attack (<6 months)
• Severe autonomic or peripheral neuropathy
• Significant acute or chronic renal failure that would preclude contrast use at CT
• Significant pulmonary fibrosis or interstitial lung disease (as assessed by a pulmonary physician)
• Physically unable to participate in high-intensity exercise
• Pregnancy
• Prior AF ablation
• A clinically significant ECG abnormality at the screening visit, which in the opinion of the investigators exposes the subject to risk by enrolling in the trial, including but not limited to: sustained ventricular tachycardia, high-grade atrioventricular block (second-degree Mobitz type II or third-degree heart block), evidence of acute ischemia (ST-segment elevation or depression >1 mm), or other arrhythmias deemed clinically significant by the study cardiologist.
• Participation in another intervention-based research study
• Inability to fully understand the instructions provided during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

36 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Patients will continue Usual Care, which will include having medication optimised for adequate heart-rate control, anti-arrhythmic therapy, and anti-coagulation (for stroke-risk) instituted by their treating Cardiologist if indicated by their CHA₂DS₂-VASc Score. Patients who remain significantly symptomatic despite attempts to optimise medical therapy may be referred for further rhythm management strategies, including cardioversion(s) and/or ablation(s) - as per current standard clinical practice. The Cardiologist will also provide routine, verbal one-off lifestyle advice in line with guidance.

Super Rehab plus Usual Care

Experimental group

Description:

12-month Super Rehab programme involving supervised dietary review sessions, 1-to-1 high-intensity exercise sessions and 3-monthly clinical review of AF risk factors, alongside Usual Care (defined above)

Treatment:

Behavioral: Super Rehab