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NCT Number: NCT03856632

Liraglutide Effect in Atrial Fibrillation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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.

RFM

Other

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 Arrhythmics

Drug

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 Ablation

Procedure

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.

Primary outcomes

  1. 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)

Secondary outcomes

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

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

    As assessed via echocardiography

  2. Change in atrial function

    Time frame: Baseline, 1 year post ablation

    As assessed via echocardiography

  3. Change in atrial size

    Time frame: Baseline, 1 year post ablation

    As assessed via echocardiography

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

    Time frame: Baseline, 1 year post ablation

    Serial changes in biomarkers of inflammation

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

    Time frame: Baseline, 1 year post ablation

    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

    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

    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

    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

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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Novel Medical Adjunctive Therapy to Catheter Ablation For Atrial Fibrillation (AF)

Acronym: LEAF

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2019
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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