Clinical trial

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

Name

20181182

Description

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.

Trial arms

Trial start

2019-03-18

Estimated PCD

2024-12-31

Trial end

2024-12-31

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Liraglutide

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.

Arms:

RFM plus Liraglutide

RFM

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.

Arms:

RFM plus Liraglutide, Risk Factor Modification (RFM)

Anti Arrhythmics

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.

Arms:

RFM plus Liraglutide, Risk Factor Modification (RFM)

Afib Catheter Ablation

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.

Arms:

RFM plus Liraglutide, Risk Factor Modification (RFM)

Size

Primary endpoint

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

Baseline, 3 months (prior to ablation)

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2024-03-28

1 organization

2 products

1 indication

Organization

Product

Indication

Product