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

August 6, 2025 updated by: Royal United Hospitals Bath NHS Foundation Trust

Effectiveness of a Novel Intervention (Super Rehab) in Overweight Patients With Atrial Fibrillation (SuRe AF), a Randomised Controlled Trial.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospitals Bath NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
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.
Experimental: Super Rehab plus Usual Care
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
A 12-month healthcare-delivered lifestyle intervention involving exercise, nutritional support and optimisation of AF-related clinical risk factors.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptom burden, as defined by the University of Toronto Atrial Fibrillation Severity Scale (AFSS)
Time Frame: Month 12
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
% burden of AF
Time Frame: Month 12
Differences between groups of the AF burden - defined as the duration of time spent in atrial fibrillation, as assessed via implantable cardiac monitor (ICM) - will be assessed at 12 months, with additional measurements conducted and reported at 6- and 15-month time points.
Month 12
Duration and number of AF episodes
Time Frame: Month 12
Differences between groups in AF duration and frequency will be assessed at 12 months, via implantable cardiac monitor (ICM), with additional measurements conducted and reported at 6- and 15-month time points.
Month 12
Time to first arrhythmia recurrence
Time Frame: Month 12
Defined as the time from normal rhythm to the earliest documented date of AF, recorded via implantable cardiac monitor (ICM), following a DCCV or ablation where ICM data was available prior to the intervention.
Month 12
Anthropometrics - Body weight
Time Frame: 12 months
Change in weight between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points.
12 months
Anthropometrics - body mass index
Time Frame: Month 12
Change in body mass index (BMI) between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- 15-month time points.
Month 12
Anthropometrics - abdominal waist circumference
Time Frame: Month 12
Change in abdominal waist circumference between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- 15-month time points.
Month 12
Cardiorespiratory fitness
Time Frame: Month 12
Differences between groups of the measured maximum rate of oxygen consumption attainable during physical exertion (VO2 peak) will be assessed via cardio pulmonary exercise test (CPET) at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points:
Month 12
Visceral fat
Time Frame: Month 12
Differences between groups of the measured visceral fat will be assessed at 12 months (via DEXA body composition scan), with additional evaluations conducted and reported at 6- and 15-month time points.
Month 12
Cardiac structural and functional assessment with echocardiography
Time Frame: Month 12
Change in left atrial size and strain between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points.
Month 12
CTCA based changes in left atrial structure
Time Frame: Month 12
Differences in peri-atrial fat volume and inflammatory signal - assessed by cardiac CT - will be evaluated between groups at 12 months
Month 12
Blood pressure control
Time Frame: Month 12
Differences between groups in both systolic and diastolic BP control, using a 7-day home blood pressure diary, will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Month 12
Serum lipid levels
Time Frame: Month 12
Differences between groups in serum lipid levels will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Month 12
Glucose control (HbA1c)
Time Frame: Month 12
Differences between groups in serum HbA1c levels will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Month 12
Inflammatory marker (high-sensitivity C-reactive protein)
Time Frame: Month 12
Differences between groups in serum CRP levels will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Month 12
Physical activity
Time Frame: 12 months
Differences in physical activity between groups, as defined by the implantable cardiac monitor (ICM), will be assessed at 12 months with additional evaluations conducted and reported at 6- and 15-month time points.
12 months
European Heart Rhythm Association (EHRA) AF-score
Time Frame: Month 12
The EHRA AF scale ranges from 1 (no symptoms) to 4 (disabling symptoms). Differences between groups will be assessed at 12 months with additional evaluations conducted and reported at the 6- and 15 month time points.
Month 12
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire
Time Frame: Month 12
The AFEQT questionnaire involves responses to a 20-item questionnaire that are scored on a 1 to 7 Likert scale (ranging from 1: "Not at all" to 7: "Extremely"). The four subscales of AFEQT are: Symptoms, Daily activities, Treatment concern and Treatment satisfaction. Overall and subscale scores range from 0 for worst to 100 for best quality of life. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Month 12
EuroQol Group (EuroQol) EQ-5D-5L questionnaire
Time Frame: Month 12
Patient reported health-related quality-of-life will be recorded using the EuroQol EQ-5D-5L questionnaire. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6-month and 15-month time points.
Month 12
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Month 12
Hospital Anxiety and Depression Scale (HADS) questionnaire. Scores range from 0 to 21 with higher scores reflecting a higher degree of anxiety and/or depression. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at the 6- and 15-month time points.
Month 12
ICEpop CAPability measure for Adults (ICECAP-A)
Time Frame: Month 12
The ICEpop CAPability measure for Adults (ICECAP-A) will assess holistic capability changes over time as part of a health economic assessment. Scores range from 5 to 20, with higher scores reflecting higher levels of capability. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at the 6- and 15-month time points.
Month 12
Resource-use questionnaire
Time Frame: Month 12
A study-specific resource-use questionnaire will record health economic parameters including medication burden, primary and secondary care interactions, impact of AF on work status, and smoking status. Differences between groups will be assessed at 12 months, with additional evaluations conducted and reported at 6- and 15-month time points.
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Royal United Hospitals Bath NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oxford
Biotronik SE & Co. KG
University of Bath
RUHX (Official NHS Charity for RUH Bath)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali Khavandi, Royal United Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RUH Bath NHS SR AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Requests for data sharing will be reviewed on an individual basis upon request to the research team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Super Rehab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings