Clinical trial

Outcome of Overweight AF Patients Following Ablation With a Potential Weight Loss Medication ( GOAL-AF )

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05221229

Active, not recruitingNot applicableObservational

What this study is about

Atrial Fibrillation (AF) is the most common abnormal heart rhythm(arrhythmia) affecting about one in 40 people in England. Patients with AF often have symptoms ranging from palpitations and breathlessness, and a small number of patients may develop heart failure. The major complication of AF is stroke, and this is effectively treated with blood thinning medications (anticoagulation). AF symptoms can lead to significant decline in quality of life and can affect patients' ability to work and exercise. There are numerous treatments targeted at maintaining normal rhythm and preventing AF recurrence. These include medications and catheter ablation. Ablation has been shown to be more effective than medications for the long-term control of AF, but its efficacy is significantly reduced by upstream conditions such as high blood pressure, obesity, diabetes, and poor fitness levels. This results in increased complications, repeat procedures, and increased AF recurrence or patients. Research currently available has shown that intensive risk factor control with weight loss and increased fitness can reduce AF burden and improve results from ablation. However, achieving these targets outside of a clinical trial have been challenging. Recent data has shown that a new class of drug (Liraglutide) can result in significant weight loss over a 3-month period, and pre-treatment prior to liver transplant has improved results and patient recovery. The overall aim of this study is to determine if accelerated weight loss by Liraglutide before AF ablation is feasible to base a future trial to inform if this approach improves outcomes and can be safely adopted into routine clinical practice.

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, Recurrence, Overweight and Obesity, Liraglutide

Full registry criteria

Inclusion criteria: Patients with symptomatic paroxysmal or persistent Atrial Fibrillation on the waiting list for AF ablation at Queen Elizabeth Hospital Birmingham who 1. are more than 18 and less than 80 of age, 2. have paroxysmal or persistent AF, 3. symptomatic: palpitations, shortness of breath, feeling of an irregular pulse or pause in heart activity, light-headedness, or dizziness) despite pharmacological anti-arrhythmic agents (or inability to take medications) therefore making them eligible for ablation therapy, 4. are above BMI- 30 kg/m2 Exclusion criteria: Any one of the followings; 1. unable to undergo CMR, 2. Patients who are currently treated with a weight losing drug - including Orlistat, GLP-1 analogues or have had/or awaiting bariatric surgery, 3. Type 1 diabetes, 4. Type 2 diabetes on DPP-IV inhibitor or insulin: as blood sugar will need close monitoring on GLP-1 and insulin, 5. Patients with decompensated liver disease, end-stage renal disease or eGFR \<30, NYHA class III/IV heart failure or active malignancy, 6. Any malignancy within the last 2 years except skin malignancies, 7. Pregnancy, 8. Patients with a history of thyroid cancer or pancreatitis, 9. Patients with a needle phobia.

Treatments and study arms

Liraglutide plus upstream risk factors modification advice and consultation

Drug

Patients will be on treatment with daily injections of Liraglutide for a total of 65 weeks. During initial consultation for AF ablation, patients' BMI, risk factors status and baseline blood tests were performed and reviewed. Then the patients were discussed and encouraged to achieve optimal goal of risk factors modifications by non pharmacological and pharmacological measures.

Primary outcomes

Adherence to Liraglutide by AF patients before and after first-time ablation [Time Frame- 13 weeks before and 52 weeks after ablation]13 weeks before and 52 weeks after ablation

Adherence to medication: will be measured by the proportion of patients who tolerate total cumulative dose of 657 mg and more of Liraglutide at the end of follow up period (minimal maintenance dose of 1.8mg over 365 days).

Number of participants recruited over recruitment period [Time Frame-39 weeks]39 weeks

The internal audit data identified, over a 2-year period, 112 patients for first time ablation with a BMI above 30. There are no competing studies, and the investigators do not expect a recruitment period of more than 39 weeks.

Accelerated weight loss by Liraglutide on AF patients before first-time ablation and during one year follow-up [Time Frame- 13 weeks from recruitment and 52 weeks after ablation]13 weeks from recruitment and 52 weeks after ablation

Weight loss: Body mass change will be measured using a single set of calibrated scales using a standardised protocol. Weight in kilograms will be measured to calculate Body Mass Index (BMI). The proportion of patients achieving \>10% weight loss, 5-9% and \< 5% weight loss will be calculated.

Study locations

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

University Hospitals Birmingham NHS Foundation Trust🇬🇧 Birmingham, West Midlands, United Kingdom

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