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GLP-1 Receptor Agonist

Liraglutide for Atrial Fibrillation (LEAF Trial)

Phase 4

Waitlist Available

Led By Jeffrey Goldberger, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Poorly controlled type 2 diabetes with HbA1c > 10%

Patients with longstanding persistent atrial fibrillation of more than 3 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 year post ablation

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial will test if a medication can help reduce the size of fat deposits around the heart, which may help stabilize heart rhythm.

Who is the study for?

Adults over 18 with a BMI of at least 27 kg/m2 and persistent or paroxysmal atrial fibrillation, who are planning to undergo catheter ablation and receive care at the University of Miami. Excluded are those with contraindications to Liraglutide, poorly controlled diabetes, pregnant or breastfeeding women, long-term AF over 3 years, unsuitable for ablation, short life expectancy, certain medication users including other GLP-1 analogs or DPP4 inhibitors.

What is being tested?

The trial is testing whether Liraglutide can reduce epicardial adipose tissue (EAT) around the heart and stabilize atrial fibrillation. Participants will be given Liraglutide alongside their planned catheter ablation procedure for AFib treatment.

What are the potential side effects?

Liraglutide may cause side effects such as pancreatitis or allergic reactions in some individuals. It's important that participants do not have a history of these conditions as they could increase the risk of experiencing severe side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My AFib lasts for more than 7 days or stops on its own within 7 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My type 2 diabetes is not well-managed, with an HbA1c over 10%.

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I have had atrial fibrillation for more than 3 years.

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I have had a procedure to treat irregular heartbeat.

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I have never had pancreatitis or thyroid cancer.

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I or my family have a history of multiple endocrine neoplasias.

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I am unable to understand or sign the consent form.

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I am currently taking diabetes medication like glitazones or SGLT2 inhibitors.

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I am currently breastfeeding or planning to get pregnant.

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I cannot undergo catheter ablation due to conditions like thyroid issues or severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 year post ablation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 year post ablation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year post ablation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in C-Reactive Protein (CRP) value

Change in Interleukin-6 (IL-6)

Change in atrial function

+6 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RFM plus LiraglutideExperimental Treatment4 Interventions

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.

Group II: Risk Factor Modification (RFM)Active Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liraglutide

2013

Completed Phase 4

~2680

Anti Arrhythmics

2019

Completed Phase 3

~30