Clinical trial NCT05596175: Super-Rehab: a Novel Approach to Reverse Atrial Fibrillation
Official title: "Super Rehab": A Novel Approach to Reverse Atrial Fibrillation (a Randomised Controlled Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Overweight and Obesity
Keywords: Lifestyle risk reduction
Exercise
Behavior modifications
Nutrition therapy
Diet
Cardiovascular disease
Lead sponsor: Royal United Hospitals Bath NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Bath
name: University of Oxford
name: Biotronik SE & Co. KG
name: RUHX (Official NHS Charity for RUH Bath)
First posted: 2022-10-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients randomized to Usual Care or Super Rehab plus Usual Care
Primary purpose: TREATMENT

Brief 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.

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 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.

Eligibility criteria: 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 or ≥ moderate disease in ≥3 major epicardial vessels
* 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
* Severe autonomic or peripheral neuropathy
* Acute systemic illness of fever
* Significant acute or chronic renal failure
* Pulmonary fibrosis or interstitial lung disease
* Physically unable to participate in high-intensity exercise
* Pregnancy
* Prior atrial fibrillation 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
* Participation in another intervention-based research study
* Inability to fully understand the instructions provided during the study

Primary outcomes:
measure: Difference in symptoms, as defined by the University of Toronto Atrial Fibrillation Severity Scale
timeFrame: Month 15
Secondary outcomes:
measure: Freedom from AF at 12-months
timeFrame: Month 12
measure: Change in burden of AF
timeFrame: Month 15
measure: Time to arrhythmia recurrence
timeFrame: Month 15
measure: Change in stroke risk - defined by Atriomic Stroke Algorithm
timeFrame: Month 12
measure: Change in stroke risk - defined by CHA₂DS₂-VASc
timeFrame: Month 12
measure: Change in atrial fibrillation symptoms, as defined by the European Heart Rhythm Association (EHRA) AF-score
timeFrame: Month 15
measure: Change in patient reported health-related quality-of-life, measured with the EuroQol Group (EuroQol) EQ-5D-5L questionnaire
timeFrame: Month 15
measure: Change atrial fibrillation specific quality of life with the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire
timeFrame: Month 15
measure: Change in self-perceived mental health, assessed with the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Month 15
measure: Change in measure of capability
timeFrame: Month 15
measure: Change in resource-use, measured with a study specific resource-use questionnaire
timeFrame: Month 15
measure: Change in serum lipid levels
timeFrame: Month 15
measure: Change in glucose control, measured with the glycated haemoglobin test (HbA1c)
timeFrame: Month 15
measure: Inflammatory markers (e.g. high-sensitivity C-reactive protein)
timeFrame: Month 15
measure: Anthropometrics - abdominal waist circumference
timeFrame: Month 15
measure: Anthropometrics - body mass index
timeFrame: Month 15
measure: Body composition
timeFrame: Month 15
measure: Cardiorespiratory fitness
timeFrame: Month 15
measure: Blood pressure control
timeFrame: Month 15
measure: Cardiac structural assessment with echocardiography
timeFrame: Month 15
measure: Cardiac systolic function assessment with echocardiography measure of left ventricular ejection fraction
timeFrame: Month 15
measure: Cardiac systolic function assessment with echocardiography of left ventricular strain
timeFrame: Month 15
measure: Cardiac diastolic function assessment with echocardiography measurement of left ventricular filling pressure
timeFrame: Month 15
measure: Echocardiography left atrial strain assessment
timeFrame: Month 15
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath NHS Foundation Trust
Study officials:
affiliation: Royal United Hospital NHS Foundation Trust
name: Ali Khavandi
role: PRINCIPAL_INVESTIGATOR
References: