Super-Rehab: a Novel Approach to Treat Atrial Fibrillation

NCT05596175 | Active Not Recruiting DMC

• 1 other identifier: RUH Bath NHS SR AF
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Overweight and Obesity

Keywords

Lifestyle risk reduction; Exercise; Behavior modifications; Nutrition therapy; Diet; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Symptom burden, as defined by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)

  As the primary outcome, an atrial fibrillation-specific measure of symptoms and quality of life will be assessed using the University of Toronto Atrial Fibrillation Severity Scale (AFSS) questionnaire. Scores range from 0 to 35, with higher scores indicating greater AF symptom severity. Differences between groups will be assessed at 12 months, with additional assessments conducted and reported at 6- and 15-month time points.

  Month 12

Secondary Outcomes (21)

• % burden of AF

  Month 12

• Duration and number of AF episodes

  Month 12

• Time to first arrhythmia recurrence

  Month 12

• Anthropometrics - Body weight

  12 months

• Anthropometrics - body mass index

  Month 12

Study Arms (2)

Usual Care

NO INTERVENTION

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

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)

Behavioral: Super Rehab

Interventions

Super Rehab BEHAVIORAL

A 12-month healthcare-delivered lifestyle intervention involving exercise, nutritional support and optimisation of AF-related clinical risk factors.

Super Rehab plus Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead
• University of Bath: collaborator
• University of Oxford: collaborator
• Biotronik SE & Co. KG: collaborator
• RUHX (Official NHS Charity for RUH Bath): collaborator

Study Sites (1)

Royal United Hospitals Bath NHS Foundation Trust

Bath, BA1 3NG, United Kingdom

Location

Related Publications (1)

• Murphy D, Graby J, Smith T, Peacock O, Abramik J, Antoniades C, Rodrigues JCL, Thompson D, Khavandi A. Effectiveness of a novel intervention (Super Rehab) in overweight patients with atrial fibrillation (SuRe AF): protocol for a randomised controlled trial. BMJ Open. 2025 Sep 14;15(9):e103090. doi: 10.1136/bmjopen-2025-103090.

  PMID: 40953861 DERIVED

Related Links

• Research team website outlining research goals

MeSH Terms

Conditions

Atrial Fibrillation; Overweight; Obesity; Risk Reduction Behavior; Motor Activity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Behavior

Study Officials

• Ali Khavandi

  Royal United Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is not possible to blind either the participant or care providers to their study arm, however the outcome analysis will be undertaken blinded to study arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients randomized to Usual Care or Super Rehab plus Usual Care

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 27, 2022
• Study Start: April 3, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)