Liraglutide Effect in Atrial Fibrillation (LEAF)

University of Miami

Status and phase: Active, not recruiting; Phase 4

Conditions: Atrial Fibrillation

Treatments: Procedure: Afib Catheter Ablation; Drug: Liraglutide; Other: RFM; Drug: Anti Arrhythmics

Study type: Interventional

Funder types: Other

Identifiers

NCT03856632

20181182

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Risk Factor Modification (RFM)

Active Comparator group

Description:

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:

Drug: Anti Arrhythmics

Other: RFM

Procedure: Afib Catheter Ablation

RFM plus Liraglutide

Experimental group

Description:

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.

Treatment:

Drug: Anti Arrhythmics

Other: RFM

Drug: Liraglutide

Procedure: Afib Catheter Ablation