Atrial FibrillationPhase 4LEAFNCT03856632
Liraglutide Effect in Atrial Fibrillation
A Phase 4 study testing Liraglutide, RFM and Anti Arrhythmics in people with Atrial Fibrillation, run by University of Miami at 1 site in United States.
Trial summary
The goal (or purpose) of this study is to evaluate (study) a new way to stabilize (steady) the activity between the fat deposits surrounding the heart and the left atrium. To reduce the amount of EAT, this study will use a medication called Liraglutide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Liraglutide, RFM and Anti Arrhythmics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2019to 31 Dec 2026
- Phase
- Phase 4
- 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
Who may be able to join
- Male and female, age 18 or older
- Persistent AF defined as continuous AF sustained beyond 7 days (or AF with the decision to cardiovert before 7 days of enrollment or Paroxysmal AF defined as recurrent AF (≥2 episodes) that terminates spontaneously within 7 days
- BMI ≥27 kg/m2
- Patient wishes to undergo a catheter ablation procedure for the treatment of atrial fibrillation
- Receiving follow-up care at the University of Miami
Who cannot join
- Inability to sign an informed consent
- Patients with longstanding persistent atrial fibrillation of more than 3 years
- Prior ablation for atrial fibrillation
- Patients not appropriate candidates for catheter ablation such as those with AF due to acute or chronic precipitating medical conditions, for example, hypothyroidism and hyperthyroidism, significant pulmonary disease, pulmonary embolism, left atrial thrombus, class IV heart failure)
- Patients with a life expectancy <1 year
- Patients with a serious medical condition (for example, recent cancer with chemotherapy or radiation therapy within 4 weeks before entering the study) who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
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- Known contraindications to Liraglutide, such as the previous history of pancreatitis or medullary thyroid carcinoma
- Personal or family history of multiple endocrine neoplasias
- Known serious hypersensitivity reaction to Liraglutide
- Patients using, glitazones, sodium-glucose transporters 2 inhibitors (SGLT2i), other GLP-1 analogs, or DPP4 inhibitors
- Type 1 diabetes, defined by American Diabetes Association criteria, history of diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes due to pancreatitis or pancreatectomy
- Poorly controlled type 2 diabetes with HbA1c > 10%
- Pregnant women
- Women who are breast-feeding or intend to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Medical Adjunctive Therapy to Catheter Ablation For Atrial Fibrillation (AF)
The goal (or purpose) of this study is to evaluate (study) a new way to stabilize (steady) the activity between the fat deposits surrounding the heart and the left atrium.
To reduce the amount of EAT, this study will use a medication called Liraglutide. This medication is known to work on fat deposits and produce weight loss. The investigator is conducting this study to find out if Liraglutide will reduce the fat deposits surrounding the participant's heart, and stabilize (and perhaps reduce or eliminate) atrial fibrillation activity.
- Conditions
- Atrial Fibrillation
- Being tested
- Liraglutide, RFM, Anti Arrhythmics, Afib Catheter Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Liraglutide will be administered with a starting dose of 0.6 mg once daily and subsequent increments to 1.2 mg once daily (after at least one week) and to 1.8 mg once daily (after at least a week on 1.2 mg). This will be taken for 3 consecutive months in conjunction with RFM program prior to catheter ablation. Treatment will resume post ablation and will be continue for 6 months.
RFMOther
The program involves weight management and exercise regimen (30 minutes for 2 to 4 times a week), hyperlipidemia management (lifestyle measure changes and initiation of statins and fibrates if necessary), management of obstructive sleep apnea (initiation of Continuous Positive Airway Pressure (CPAP) if necessary), management of hypertension (reduction of salt intake, initiation of Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin II Receptor blockers (ARB) medications if necessary), diabetes management (lifestyle measure changes, endocrine review and initiation of metformin if necessary) and smoking cessation and alcohol abstinence or reduction. This program will be performed at start of study participation all throughout the follow up period.
Anti ArrhythmicsDrug
The choice of antiarrhythmic drug will be at the discretion of the managing physician, but will generally include either a class IC or class III antiarrhythmic drug. If necessary, and clinically indicated, amiodarone may be used. Therapy will be initiated at the start of study participation and will be discontinued 6-12 weeks after the ablation, as deemed clinically appropriate by the managing electrophysiologist.
Afib Catheter AblationProcedure or surgery
The procedure will be performed according to usual clinical practice. The primary approach will be antral pulmonary vein isolation (PVI), preferably performed by cryoballoon ablation, though radiofrequency may be used as deemed necessary by the operator for clinical reasons. This will be performed after 3 months of RFM or RFM + Liraglutide program.
| Study group | Role | What they receive |
|---|---|---|
| Risk Factor Modification (RFM) | Active comparator | A structured risk factor modification (RFM) program currently offered to all patients who are overweight or obese undergoing an ablation procedure for atrial fibrillation.The RFM program is already offered through our Center for Atrial Fibrillation and is managed by a nurse practitioner. The RFM program will provide patient teaching and education on weight, fitness,blood pressure control, glucose control, cholesterol, sleep apnea, smoking, and alcohol. Receives: Other: RFM; Drug: Anti Arrhythmics; Procedure: Afib Catheter Ablation |
| RFM plus Liraglutide | Experimental | In addition to RFM, Liraglutide will be administered. Liraglutide is an FDA approved medication used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management of obese adults with weight-related comorbid conditions. Receives: Drug: Liraglutide; Other: RFM; Drug: Anti Arrhythmics; Procedure: Afib Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in size of Left Atrial Epicardial Adipose Tissue (LAEAT)
As assessed via multi detector cardiac computer tomography (MD-CT)
Measured: Baseline, 3 months (prior to ablation)
Secondary outcomes (9)
Change in size of Epicardial Adipose Tissue (EAT) thickness
As assessed via echocardiography
Measured: Baseline, 3 months (prior to ablation), 1 year post-ablation
Change in atrial function
As assessed via echocardiography
Measured: Baseline, 1 year post ablation
Change in atrial size
As assessed via echocardiography
Measured: Baseline, 1 year post ablation
Change in C-Reactive Protein (CRP) value
Serial changes in biomarkers of inflammation
Measured: Baseline, 1 year post ablation
Change in Interleukin-6 (IL-6)
Serial changes in biomarkers of inflammation
Measured: Baseline, 1 year post ablation
Correlation of CRP expression in blood from left atrium to peripheral plasma
At the same time point, blood will be collected directly from left atrium and peripheral vessel during the ablation procedure and compared
Measured: During the catheter ablation procedure
Correlation of IL-6 expression in blood from left atrium to peripheral plasma
At the same time point blood, will be collected directly from left atrium and the peripheral vessel during the ablation procedure and compared
Measured: During the catheter ablation procedure
Correlation of plasminogen activator inhibitor (PAI-1), matrix metalloproteinase-2 (MMP2), Tissue inhibitor of metalloproteinase 2 (TIMP-2)
At the same time point, blood will be collected directly from left atrium and the peripheral vessel during the ablation procedure and compared
Measured: During the catheter ablation procedure
Correlation of atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP)
At the same time point, blood will be collected directly from left atrium and the peripheral vessel during the ablation procedure and compared
Measured: During the catheter ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start18 Mar 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Goldberger, University of Miami
- Investigators
- Jeffrey Goldberger, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856632
- Sponsor's protocol ID
- 20181182
- Acronym
- LEAF
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2019
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldberger JJ, Mitrani RD, Fishman J, Zaatari G, Lowery M, Baez-Garcia C, Aguilar V, Blandon C, Hurwitz BE, Velasquez AH, Lambrakos LK, Dey D, Zarnegarnia Y, Iacobellis G. The Liraglutide Effects in Atrial Fibrillation (LEAF) Study. JACC Clin Electrophysiol. 2026 Mar 30:S2405-500X(26)00270-7. doi: 10.1016/j.jacep.2026.03.026. Online ahead of print.
PubMed 42159524
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Medical Adjunctive Therapy to Catheter Ablation For Atrial Fibrillation (AF)
- ClinicalTrials.gov ID
- NCT03856632
- Acronym / sponsor ID
- LEAF / 20181182
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2019 (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.
The goal (or purpose) of this study is to evaluate (study) a new way to stabilize (steady) the activity between the fat deposits surrounding the heart and the left atrium.
To reduce the amount of EAT, this study will use a medication called Liraglutide. This medication is known to work on fat deposits and produce weight loss. The investigator is conducting this study to find out if Liraglutide will reduce the fat deposits surrounding the participant's heart, and stabilize (and perhaps reduce or eliminate) atrial fibrillation activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk Factor Modification (RFM) | Active comparator | Other: RFM, Drug: Anti Arrhythmics, Procedure: Afib Catheter AblationA structured risk factor modification (RFM) program currently offered to all patients who are overweight or obese undergoing an ablation procedure for atrial fibrillation.The RFM program is already offered through our Center for Atrial Fibrillation and is managed by a nurse practitioner. The RFM program will provide patient teaching and education on weight, fitness,blood pressure control, glucose control, cholesterol, sleep apnea, smoking, and alcohol. |
| RFM plus Liraglutide | Experimental | Drug: Liraglutide, Other: RFM, Drug: Anti Arrhythmics, Procedure: Afib Catheter AblationIn addition to RFM, Liraglutide will be administered. Liraglutide is an FDA approved medication used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management of obese adults with weight-related comorbid conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female, age 18 or older
- Persistent AF defined as continuous AF sustained beyond 7 days (or AF with the decision to cardiovert before 7 days of enrollment or Paroxysmal AF defined as recurrent AF (≥2 episodes) that terminates spontaneously within 7 days
- BMI ≥27 kg/m2
- Patient wishes to undergo a catheter ablation procedure for the treatment of atrial fibrillation
- Receiving follow-up care at the University of Miami
Key exclusion criteria (14 listed)
- Inability to sign an informed consent
- Patients with longstanding persistent atrial fibrillation of more than 3 years
- Prior ablation for atrial fibrillation
- Patients not appropriate candidates for catheter ablation such as those with AF due to acute or chronic precipitating medical conditions, for example, hypothyroidism and hyperthyroidism, significant pulmonary disease, pulmonary embolism, left atrial thrombus, class IV heart failure)
- Patients with a life expectancy <1 year
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 |
|---|---|---|
| LiraglutideLiraglutide will be administered with a starting dose of 0.6 mg once daily and subsequent increments to 1.2 mg once daily (after at least one week) and to 1.8 mg once daily (after at least a week on 1.2 mg). This will be taken for 3 consecutive months in conjunction with RFM program prior to catheter ablation. Treatment will resume post ablation and will be continue for 6 months. | Drug | RFM plus Liraglutide |
| RFMThe program involves weight management and exercise regimen (30 minutes for 2 to 4 times a week), hyperlipidemia management (lifestyle measure changes and initiation of statins and fibrates if necessary), management of obstructive sleep apnea (initiation of Continuous Positive Airway Pressure (CPAP) if necessary), management of hypertension (reduction of salt intake, initiation of Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin II Receptor blockers (ARB) medications if necessary), diabetes management (lifestyle measure changes, endocrine review and initiation of metformin if necessary) and smoking cessation and alcohol abstinence or reduction. This program will be performed at start of study participation all throughout the follow up period. | Other | RFM plus Liraglutide, Risk Factor Modification (RFM) |
| Anti ArrhythmicsThe choice of antiarrhythmic drug will be at the discretion of the managing physician, but will generally include either a class IC or class III antiarrhythmic drug. If necessary, and clinically indicated, amiodarone may be used. Therapy will be initiated at the start of study participation and will be discontinued 6-12 weeks after the ablation, as deemed clinically appropriate by the managing electrophysiologist. | Drug | RFM plus Liraglutide, Risk Factor Modification (RFM) |
| Afib Catheter AblationThe procedure will be performed according to usual clinical practice. The primary approach will be antral pulmonary vein isolation (PVI), preferably performed by cryoballoon ablation, though radiofrequency may be used as deemed necessary by the operator for clinical reasons. This will be performed after 3 months of RFM or RFM + Liraglutide program. | Procedure or surgery | RFM plus Liraglutide, Risk Factor Modification (RFM) |
Primary outcome
Change in size of Left Atrial Epicardial Adipose Tissue (LAEAT)
Time frame: Baseline, 3 months (prior to ablation)
As assessed via multi detector cardiac computer tomography (MD-CT)
9 secondary outcomes
Change in size of Epicardial Adipose Tissue (EAT) thickness
Time frame: Baseline, 3 months (prior to ablation), 1 year post-ablation
Change in atrial function
Time frame: Baseline, 1 year post ablation
Change in atrial size
Time frame: Baseline, 1 year post ablation
Change in C-Reactive Protein (CRP) value
Time frame: Baseline, 1 year post ablation
Change in Interleukin-6 (IL-6)
Time frame: Baseline, 1 year post ablation
Correlation of CRP expression in blood from left atrium to peripheral plasma
Time frame: During the catheter ablation procedure
Correlation of IL-6 expression in blood from left atrium to peripheral plasma
Time frame: During the catheter ablation procedure
Correlation of plasminogen activator inhibitor (PAI-1), matrix metalloproteinase-2 (MMP2), Tissue inhibitor of metalloproteinase 2 (TIMP-2)
Time frame: During the catheter ablation procedure
Correlation of atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP)
Time frame: During the catheter ablation procedure
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 1 May 2026.
- Derived from this study: PubMed 42159524Goldberger JJ, Mitrani RD, Fishman J, Zaatari G, Lowery M, Baez-Garcia C, Aguilar V, Blandon C, Hurwitz BE, Velasquez AH, Lambrakos LK, Dey D, Zarnegarnia Y, Iacobellis G. The Liraglutide Effects in Atrial Fibrillation (LEAF) Study. JACC Clin Electrophysiol. 2026 Mar 30:S2405-500X(26)00270-7. doi: 10.1016/j.jacep.2026.03.026. Online ahead of print.
- 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.
Jeffrey Goldberger, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide, RFM and Anti Arrhythmics in people with Atrial Fibrillation, run by University of Miami at 1 site in United States.
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 14 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 1 May 2026. 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 States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in size of Left Atrial Epicardial Adipose Tissue (LAEAT) (time frame: Baseline, 3 months (prior to ablation)). 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 NCT03856632, 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 1 May 2026.