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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 year post ablation
Awards & highlights
LEAF Trial 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.Check my eligibility
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.See study design
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.
LEAF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My AFib lasts for more than 7 days or stops on its own within 7 days.
LEAF Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in size of Left Atrial Epicardial Adipose Tissue (LAEAT)
Secondary outcome measures
Change in C-Reactive Protein (CRP) value
Change in Interleukin-6 (IL-6)
Change in atrial function
+6 moreLEAF 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
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
900 Previous Clinical Trials
409,872 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
104,394 Patients Enrolled for Atrial Fibrillation
Jeffrey Goldberger, MDPrincipal Investigator - University of Miami
A Einstein College Of Medical Of Yeshiva University (Medical School)
University Ca Sf School Of Medicine (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious allergic reaction to liraglutide.I want to have a procedure to treat my irregular heartbeat.My type 2 diabetes is not well-managed, with an HbA1c over 10%.I have recovered from any serious illness or treatments I received more than 4 weeks ago.I have had atrial fibrillation for more than 3 years.I have had a procedure to treat irregular heartbeat.I have never had pancreatitis or thyroid cancer.You have type 1 diabetes, a history of diabetic ketoacidosis, or diabetes due to pancreatitis or pancreatectomy.I or my family have a history of multiple endocrine neoplasias.I am unable to understand or sign the consent form.My AFib lasts for more than 7 days or stops on its own within 7 days.I am currently taking diabetes medication like glitazones or SGLT2 inhibitors.I am currently breastfeeding or planning to get pregnant.You are expected to live for less than 1 year.I cannot undergo catheter ablation due to conditions like thyroid issues or severe heart failure.You have a body mass index (BMI) of 27 or higher.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Risk Factor Modification (RFM)
- Group 2: RFM plus Liraglutide
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT03856632 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently partaking in this trial?
"Correct. As indicated on the clinicaltrials.gov website, this medical research is actively recruiting participants - first posted on March 18th 2019 and lastly updated on April 28th 2022- with a goal of enrolling 60 patients in one centre."
Answered by AI
Are there current opportunities to join this research experiment?
"Clinicaltrials.gov attests that this experiment is currently enrolling participants, with its initiation being on March 18th 2019 and the last modification taking place on April 28th 2022."
Answered by AI
Has the FDA sanctioned Liraglutide for clinical use?
"The safety profile of liraglutide is highly reliable, garnering it a score of 3 due to Phase 4 trials confirming its efficacy and market approval."
Answered by AI
To which maladies is Liraglutide typically employed?
"Liraglutide is routinely prescribed to treat exercise-induced conditions, as well as inadequate control on monotherapy, cardiovascular risk reduction and CVD."
Answered by AI
Who else is applying?
What state do they live in?
California
Alabama
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
What questions have other patients asked about this trial?
How is the success measured of this trial? If successful will trial members be able to continue the medication?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I am on multiple medications to control heart rhythm, if there is an intervention that could reduce or eliminate using these medications, that would be a life changer.
PatientReceived no prior treatments
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