Clinical trial

Super-Rehab: a Novel Approach to Treat Atrial Fibrillation

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05596175

Active, not recruitingNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionAtrial Fibrillation, Overweight and Obesity

Full registry 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 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

Treatments and study arms

Super Rehab

Behavioral

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

Primary outcomes

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Royal United Hospitals Bath NHS Foundation Trust🇬🇧 Bath, United Kingdom