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Trial · Interventional

Active, not recruitingPhase 4Registry data

Liraglutide Effect in Atrial Fibrillation

Short name LEAF

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
60 participants (actual)
Sponsor
University of Miami · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
18 Mar 2019
Primary completion
31 Dec 2026 (estimated)
Completion
31 Dec 2026 (estimated)
First posted
27 Feb 2019
Last update posted
1 May 2026
Conditions
Atrial Fibrillation

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202220242026
  1. Ph 4

    LEAF

    NCT03856632

    18 Mar 2019 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • RFMOther
  • Anti ArrhythmicsDrug
  • Afib Catheter AblationProcedure

Arms2

  • Active comparator

    Risk Factor Modification (RFM)

    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.

  • Experimental

    RFM plus Liraglutide

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in size of Left Atrial Epicardial Adipose Tissue (LAEAT)

    Time frame · Baseline, 3 months (prior to ablation)

    Registry description

    As assessed via multi detector cardiac computer tomography (MD-CT)

Secondary outcomes(9)
  1. Change in size of Epicardial Adipose Tissue (EAT) thickness

    Time frame · Baseline, 3 months (prior to ablation), 1 year post-ablation

    Registry description

    As assessed via echocardiography

  2. Change in atrial function

    Time frame · Baseline, 1 year post ablation

    Registry description

    As assessed via echocardiography

  3. Change in atrial size

    Time frame · Baseline, 1 year post ablation

    Registry description

    As assessed via echocardiography

  4. Change in C-Reactive Protein (CRP) value

    Time frame · Baseline, 1 year post ablation

    Registry description

    Serial changes in biomarkers of inflammation

  5. Change in Interleukin-6 (IL-6)

    Time frame · Baseline, 1 year post ablation

    Registry description

    Serial changes in biomarkers of inflammation

  6. Correlation of CRP expression in blood from left atrium to peripheral plasma

    Time frame · During the catheter ablation procedure

    Registry description

    At the same time point, blood will be collected directly from left atrium and peripheral vessel during the ablation procedure and compared

  7. Correlation of IL-6 expression in blood from left atrium to peripheral plasma

    Time frame · During the catheter ablation procedure

    Registry description

    At the same time point blood, will be collected directly from left atrium and the peripheral vessel during the ablation procedure and compared

  8. 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

    Registry description

    At the same time point, blood will be collected directly from left atrium and the peripheral vessel during the ablation procedure and compared

  9. Correlation of atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP)

    Time frame · During the catheter ablation procedure

    Registry description

    At the same time point, blood will be collected directly from left atrium and the peripheral vessel during the ablation procedure and compared

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

8 results

The Liraglutide Effects in Atrial Fibrillation (LEAF) Study.

Goldberger et al. 2026JACC. Clinical electrophysiologycited by 2

PMID 42159524DOI 10.1016/j.jacep.2026.03.026PUB-42159524

Full text at the publisher8 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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

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