Atrial FibrillationGOAL-AFNCT05221229
Outcome of Overweight AF Patients Following Ablation With a Potential Weight Loss Medication ( GOAL-AF )
An observational study of Atrial Fibrillation and Recurrence, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Recurrence, Overweight and Obesity
- What is being tested?
- Liraglutide plus upstream risk factors modification advice and consultation
- Type of treatment
- Injection or infusion
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Apr 2022to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2GW
About this study
Official title: Feasibility Study of GLP-1 Analogues for the Optimization of Outcomes in High BMI Patients Undergoing AbLation for Atrial Fibrillation
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.
Read more
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Recurrence, Overweight and Obesity, Liraglutide
- Being tested
- Liraglutide plus upstream risk factors modification advice and consultation
- Keywords
- Atrial Fibrillation, Liraglutide, Ablation, Biomarkers, Heart MRI(CMR)
- Medical subject headings
- Atrial Fibrillation, Recurrence, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide plus upstream risk factors modification advice and consultationDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Liraglutide plus upstream risk factors modification advice and consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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]
Time to first recurrence- any symptomatic or asymptomatic AF (>30s) beyond 12-weeks blanking post ablation as detected by Kardia recording
Recurrence of AF will be defined as a heart rhythm with no discernible p waves and irregular RR intervals, when atrioventricular conduction is not impaired on a standard 12 lead ECG or a recording of a single lead ECG tracing of equal or more than 30 seconds, by Kardia recording.
Measured: 52 weeks
AF burden after first-time AF ablation during one year follow-up [Time Frame-52 weeks]
AF burden will be quantified by twice daily and symptom-triggered (onset and termination) Kardia recordings which will be sent daily. The time of the recorded AF event will be taken as the onset of the episode, with the next recorded sinus rhythm taken as the offset. The duration of the all episodes will then be reported as percentage over predefined periods (13th-26th weeks, 27th-39th weeks, and 40th- 52nd weeks after ablation).
AF burden will be reported as percentage of total observed time.
Measured: 52 weeks
Changes in Epicardial Fat Volume as measured on heart MRI(CMR) [Time Frame- at baseline and 13 weeks]
A standardised protocol is used for MRI acquisition of the heart. For the sequences, ECG triggering is used and patients are in a breath-hold for 10-12 seconds during the acquisition period. For a correct horizontal long axes of the heart in diastole, fast-spin T1-weighted sequences with oblique axial orientation are used to obtain cardiac adipose tissue scans. Images are also acquired in the short-axis view, which covers the heart from apex of the ventricles to the top of the atria. Area is quantified for each slice, and volume(cm^3) is calculated by multiplying each area by the thickness with no gap between images.
Measured: Baseline and 13 weeks
Changes in Left Atrial Fibrosis in percentage [Time Frame- at baseline and 13 weeks]
A standardised protocol is used for MRI acquisition of the heart. For the sequences, ECG triggering is used and patients are in a breath-hold for 10-12 seconds during the acquisition period. For a correct horizontal long axes of the heart in diastole, fast-spin T1-weighted sequences with oblique axial orientation are used to obtain cardiac adipose tissue scans. Images are also acquired in the short-axis view, which covers the heart from apex of the ventricles to the top of the atria. Late Gadolinium Enhancement(15 min delayed images) will be acquired for final analysis. Then an open access rendering software, CEMRGAPP from King's College London, will be used to render images to produce left atrial fibrosis in percentage of left atrial volume.
Measured: Baseline and 13 weeks
Changes in AF biomarkers [Time Frame- at baseline and 13 weeks]
For AF biomarkers, plasma will be used by taking additional EDTA tubes. Then they are to be spun down, components separated, frozen at -20 celsius at the hospital, then transferred to IBR building of Institute of Cardiovascular Science of University of Birmingham for ROCHE testing and long-term storage at -80 celsius. FGF-23(picograms/millilitres) and BMP-10(nanograms/millilitres) will be measured quantitatively according to ROCHE testing panel.
Measured: Baseline and 13 weeks
Adherence to Kardia Recording Requirements [Time Frame- 39 weeks]
Adherence to Kardia recording requirements: will be measured by calculating the percentage of patients who upload at least 2 recordings per day after 12 weeks blanking period following ablation up to the end of follow-up period.
Measured: 39 weeks
Changes in electro-anatomic mapping data in right atrium [Time Frame -at baseline and 13 weeks]
The electrical signals of the right atrium will be recorded in electrophysiology study at the baselline and at the time of ablation. These measurements will be analysed offline for specific markers of atrial fibrillation such as low voltage measured in millivolts and conduction velocity measured in centimeters per second.
Measured: Baseline and 13 weeks
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]
The effect of this treatment approach on quality of life will be measured by undertaking questionnaires at specific time points that have been designed and validated for patients with AF.
Measured: Baseline, 13 weeks from baseline and 52 weeks after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start17 Apr 2022
- Primary completion30 Jun 2025
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Principal investigator, Manish Kalla, University Hospital Birmingham
- Investigators
- Manish Kalla, BSc, MBBS, MRCP, DPhil, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221229
- Sponsor's protocol ID
- RRK7604
- Acronym
- GOAL-AF
- Status last verified
- Jul 2025
- First submitted
- 17 Dec 2021
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38383462
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of GLP-1 Analogues for the Optimization of Outcomes in High BMI Patients Undergoing AbLation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05221229
- Acronym / sponsor ID
- GOAL-AF / RRK7604
- Conditions
- Atrial Fibrillation, Recurrence, Overweight and Obesity, Liraglutide
- Keywords
- Atrial Fibrillation, Liraglutide, Ablation, Biomarkers, Heart MRI(CMR)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 17 Apr 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Drug: Liraglutide plus upstream risk factors modification advice and consultationA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liraglutide plus upstream risk factors modification advice and consultationPatients 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. | Drug | Study Cohort |
Primary outcome
Adherence to Liraglutide by AF patients before and after first-time ablation [Time Frame- 13 weeks before and 52 weeks after 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).
Number of participants recruited over recruitment period [Time Frame-39 weeks]
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.
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]
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.
8 secondary outcomes
Recurrence of AF after first-time AF ablation during one year follow-up [Time Frame- 52 weeks]
Time frame: 52 weeks
AF burden after first-time AF ablation during one year follow-up [Time Frame-52 weeks]
Time frame: 52 weeks
Changes in Epicardial Fat Volume as measured on heart MRI(CMR) [Time Frame- at baseline and 13 weeks]
Time frame: Baseline and 13 weeks
Changes in Left Atrial Fibrosis in percentage [Time Frame- at baseline and 13 weeks]
Time frame: Baseline and 13 weeks
Changes in AF biomarkers [Time Frame- at baseline and 13 weeks]
Time frame: Baseline and 13 weeks
Adherence to Kardia Recording Requirements [Time Frame- 39 weeks]
Time frame: 39 weeks
Changes in electro-anatomic mapping data in right atrium [Time Frame -at baseline and 13 weeks]
Time frame: Baseline and 13 weeks
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]
Time frame: Baseline, 13 weeks from baseline and 52 weeks after ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Derived from this study: PubMed 38383462Win 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish Kalla, BSc, MBBS, MRCP, DPhil principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Recurrence, run by University Hospital Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Liraglutide by AF patients before and after first-time ablation [Time Frame- 13 weeks before and 52 weeks after ablation] (time frame: 13 weeks before and 52 weeks after ablation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05221229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.