A novel lifestyle intervention to reverse atrial fibrillation
"Super Rehab": A Novel Approach to Reverse Atrial Fibrillation (a Randomised Controlled Trial)
This study is testing a new lifestyle program called Super Rehab to see if it can help overweight people with atrial fibrillation feel better by making changes to their exercise, diet, and habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal United Hospitals Bath NHS Foundation Trust Academic / other |
| Locations | 1 site (Bath) |
| Trial ID | NCT05596175 on ClinicalTrials.gov |
What this trial studies
This study tests a new lifestyle intervention called Super Rehab, aimed at improving symptoms in patients with symptomatic atrial fibrillation (AF) who are overweight. Participants will receive this intervention alongside standard care, focusing on lifestyle changes such as exercise, nutrition, and behavior modifications. The primary goal is to assess the improvement in AF-related symptoms compared to usual care alone. Secondary outcomes will evaluate the burden of AF, stroke risk, and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with symptomatic atrial fibrillation and a body mass index of 27 kg/m² or higher.
Not a fit: Patients with severe cardiovascular conditions or unstable health issues may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly reduce symptoms of atrial fibrillation and improve overall cardiovascular health for patients.
How similar studies have performed: Previous studies have indicated that lifestyle modifications can positively impact atrial fibrillation, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bath
- Royal United Hospitals Bath NHS Foundation Trust — Bath, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Ali Khavandi — Royal United Hospital NHS Foundation Trust
- Study coordinator: John Graby
- Email: john.graby@nhs.net
- Phone: 01225 824160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.