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

NCT05221229 | Active Not Recruiting

• 1 other identifier: RRK7604
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Recurrence; Overweight and Obesity; Liraglutide

Keywords

Atrial Fibrillation; Liraglutide; Ablation; Biomarkers; Heart MRI(CMR)

Outcome Measures

Primary Outcomes (3)

• Adherence to Liraglutide by AF patients before and after first-time ablation [Time Frame- 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).

  13 weeks before and 52 weeks after ablation

• Number of participants recruited over recruitment period [Time Frame-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.

  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]

  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.

  13 weeks from recruitment and 52 weeks after ablation

Secondary Outcomes (8)

• Recurrence of AF after first-time AF ablation during one year follow-up [Time Frame- 52 weeks]

  52 weeks

• AF burden after first-time AF ablation during one year follow-up [Time Frame-52 weeks]

  52 weeks

• Changes in Epicardial Fat Volume as measured on heart MRI(CMR) [Time Frame- at baseline and 13 weeks]

  Baseline and 13 weeks

• Changes in Left Atrial Fibrosis in percentage [Time Frame- at baseline and 13 weeks]

  Baseline and 13 weeks

• Changes in AF biomarkers [Time Frame- at baseline and 13 weeks]

  Baseline and 13 weeks

Study Arms (1)

Study Cohort

A total of 30 patients will be included in the study group after screening of inclusion and exclusion criteria. Patients will have upstream risk factors assessed at the clinic consultation and offered risk factor optimization advice. In addition, they will received daily Liraglutide injections for 13 weeks before and 52 weeks after ablation.

Drug: Liraglutide plus upstream risk factors modification advice and consultation

Interventions

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.

Study Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Atrial Fibrillation and risk factors defined by eligibility criteria planning to go for AF ablation in Queen Elizabeth Hospital of Birmingham will be approached to enrol in our study.

You may qualify if:

• Patients with symptomatic paroxysmal or persistent Atrial Fibrillation on the waiting list for AF ablation at Queen Elizabeth Hospital Birmingham who
• are more than 18 and less than 80 of age,
• have paroxysmal or persistent AF,
• 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,
• are above BMI- 30 kg/m2

You may not qualify if:

• Any one of the followings;
• unable to undergo CMR,
• Patients who are currently treated with a weight losing drug - including Orlistat, GLP-1 analogues or have had/or awaiting bariatric surgery,
• Type 1 diabetes,
• Type 2 diabetes on DPP-IV inhibitor or insulin: as blood sugar will need close monitoring on GLP-1 and insulin,
• Patients with decompensated liver disease, end-stage renal disease or eGFR \<30, NYHA class III/IV heart failure or active malignancy,
• Any malignancy within the last 2 years except skin malignancies,
• Pregnancy,
• Patients with a history of thyroid cancer or pancreatitis,
• Patients with a needle phobia.

Sponsors & Collaborators

• University Hospital Birmingham: lead
• University of Birmingham: collaborator

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2GW, United Kingdom

Location

Related Publications (1)

• Win KZ, Armstrong M, Steeds RP, Kalla M. Feasibility study of Glucagon-like peptide-1 analogues for the optimization of Outcomes in obese patients undergoing AbLation for Atrial Fibrillation (GOAL-AF) protocol. Pilot Feasibility Stud. 2024 Feb 21;10(1):36. doi: 10.1186/s40814-024-01454-y.

  PMID: 38383462 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be taken from all patients as part of their routine care, including measurements for full blood count, urea and electrolytes, liver function test, and AF biomarkers panel.

MeSH Terms

Conditions

Atrial Fibrillation; Recurrence; Overweight; Obesity

Interventions

Liraglutide; Referral and Consultation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Manish Kalla, BSc, MBBS, MRCP, DPhil

  University Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist and Electrophysiologist

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: February 2, 2022
• Study Start: April 17, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)