Clinical trial NCT05221229: Outcome of Overweight AF Patients Following Ablation With a Potential Weight Loss Medication ( GOAL-AF )
Official title: Feasibility Study of GLP-1 Analogues for the Optimization of Outcomes in High BMI Patients Undergoing AbLation for Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Recurrence
Overweight and Obesity
Liraglutide
Keywords: Atrial Fibrillation
Liraglutide
Ablation
Biomarkers
Heart MRI(CMR)
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2022-02-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Patients meeting the inclusion criteria waiting for atrial fibrillation (AF) ablation in Queen Elizabeth Hospital of Birmingham will be invited for the study.

The investigators aim to recruit 30 patients who meet eligibility criteria. The study will be delivered by a dedicated research fellow, supported by a team of supervising clinical researchers. The research fellow will be responsible for recruitment, study data collection, and follow up. They will also be supported by clinical research nurses.

Timeline of the study for study participants:

At 1st visit (baseline): this visit will focus on collected baseline data (listed below), education on how to administer liraglutide (weight loss medication), and use the Kardia device

The following steps will be undertaken:

* Weight and height: this is standard of care
* Blood Tests: routine and additional blood tests will be taken for research
* Heart MRI: this is undertaken routinely in our clinical practice
* Provision of heart monitoring device(Kardia) and right atrial mapping will be performed: this is an additional step for the research study
* Patient reported outcome measures (PROMs) questionnaire will be completed: this is an additional step for the research study
* Liraglutide injection: the study participant will be trained to self administer this medication
* The baseline electrophysiological study (right atrial mapping) will be also be scheduled at this time point and will require an additional visit: this is a 30 minute procedure under sedation undertaken via a vein at the top of the right leg in the cardiac catheterisation laboratory (a recording of what takes place during this type of procedure will be available for patients to see before enrolment). This will be a day case procedure. The patient will not be able to drive for 48h after this procedure and will need to schedule 5-7 days off work.

At 2nd visit (13 weeks from baseline): this review time point will collect data after 13 weeks of treatment with Liraglutide

* Weight and height
* Blood Tests: these are extra blood tests done for research
* Heart MRI will be repeated: this is an extra test done for research and will require an extra visit to the hospital
* Then AF ablation with left mapping will performed as planned and right atrial mapping will be repeated at the time of AF ablation: this will be a planned admission separate to the visit for the heart MRI scan
* PROMs will be completed: this will not require an extra visit and will be done during the admission for the MRI or ablation

At 3rd visit (13 weeks from AF Ablation):

* Routine post ablation follow up in the outpatient clinic
* Remote review of Kardia recordings for AF recurrence will be performed.

At 4th visit (26 weeks from AF Ablation):

* This follow will be remote to avoid additional visits to the hospital
* Remote review of Kardia recordings for AF recurrence will be performed.

At 5th visit (39 weeks from AF Ablation):

* This follow will be remote to avoid additional visits to the hospital
* Remote review of Kardia recordings for AF recurrence will be performed.

At 6th visit (52 weeks from AF ablation): in person review and final follow up for the research study

* Weight and height check for BMI
* Review of Kardia ECG data
* PROM questionnaire for quality of life assessment
* All follow up after this will be as clinically indicated via the NHS clinic

Study design support

* The Birmingham Clinical Trials Unit has supported the design of this study with the primary outcome being feasibility of the treatment protocol
* We have also established an AF patient group with whom the study protocol, patient information sheet and consent forms have been reviewed, suggestions made and changes instituted.

Eligibility 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.

Primary outcomes:
measure: Adherence to Liraglutide by AF patients before and after first-time ablation [Time Frame- 13 weeks before and 52 weeks after ablation]
timeFrame: 13 weeks before and 52 weeks after ablation
measure: Number of participants recruited over recruitment period [Time Frame-39 weeks]
timeFrame: 39 weeks
measure: 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]
timeFrame: 13 weeks from recruitment and 52 weeks after ablation
Secondary outcomes:
measure: Recurrence of AF after first-time AF ablation during one year follow-up [Time Frame- 52 weeks]
timeFrame: 52 weeks
measure: AF burden after first-time AF ablation during one year follow-up [Time Frame-52 weeks]
timeFrame: 52 weeks
measure: Changes in Epicardial Fat Volume as measured on heart MRI(CMR) [Time Frame- at baseline and 13 weeks]
timeFrame: Baseline and 13 weeks
measure: Changes in Left Atrial Fibrosis in percentage [Time Frame- at baseline and 13 weeks]
timeFrame: Baseline and 13 weeks
measure: Changes in AF biomarkers [Time Frame- at baseline and 13 weeks]
timeFrame: Baseline and 13 weeks
measure: Adherence to Kardia Recording Requirements [Time Frame- 39 weeks]
timeFrame: 39 weeks
measure: Changes in electro-anatomic mapping data in right atrium [Time Frame -at baseline and 13 weeks]
timeFrame: Baseline and 13 weeks
measure: Changes in patient reported outcome measures (AFEQT- AF Effect on QualiTy of life) [Time Frame- at baseline, 13 weeks from baseline and 52 weeks after ablation]
timeFrame: Baseline, 13 weeks from baseline and 52 weeks after ablation
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: University Hospital Birmingham NHS Foundation Trust
name: Manish Kalla, BSc, MBBS, MRCP, DPhil
role: PRINCIPAL_INVESTIGATOR
References: