Clinical trial NCT03856632: Liraglutide Effect in Atrial Fibrillation
Official title: Novel Medical Adjunctive Therapy to Catheter Ablation For Atrial Fibrillation (AF)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Change in size of Left Atrial Epicardial Adipose Tissue (LAEAT)
timeFrame: Baseline, 3 months (prior to ablation)
Secondary outcomes:
measure: Change in size of Epicardial Adipose Tissue (EAT) thickness
timeFrame: Baseline, 3 months (prior to ablation), 1 year post-ablation
measure: Change in atrial function
timeFrame: Baseline, 1 year post ablation
measure: Change in atrial size
timeFrame: Baseline, 1 year post ablation
measure: Change in C-Reactive Protein (CRP) value
timeFrame: Baseline, 1 year post ablation
measure: Change in Interleukin-6 (IL-6)
timeFrame: Baseline, 1 year post ablation
measure: Correlation of CRP expression in blood from left atrium to peripheral plasma
timeFrame: During the catheter ablation procedure
measure: Correlation of IL-6 expression in blood from left atrium to peripheral plasma
timeFrame: During the catheter ablation procedure
measure: Correlation of plasminogen activator inhibitor (PAI-1), matrix metalloproteinase-2 (MMP2), Tissue inhibitor of metalloproteinase 2 (TIMP-2)
timeFrame: During the catheter ablation procedure
measure: Correlation of atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP)
timeFrame: During the catheter ablation procedure
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Jeffrey Goldberger, MD
role: PRINCIPAL_INVESTIGATOR
References: