# Novel medical adjunctive therapy to catheter ablation for atrial fibrillation

> **NIH NIH R01** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2020 · $650,635

## Abstract

Project Summary
Atrial fibrillation (AF) is the most common arrhythmia affecting well over 2 million people in the US with
projections that it will affect 8-12 million people by 2050. It is responsible for >$6 billion in annual health care
expenditures in the US. Catheter ablation to achieve sinus rhythm is a growing therapeutic option due to its
greater success rate compared to antiarrhythmic drug therapy. Yet, success rates for catheter ablation are
suboptimal. For patients with persistent AF, catheter ablation has even lower success rates than for those with
paroxysmal AF. The STAR AF II randomized multicenter clinical trial reported an average freedom from AF
after one procedure of 50% for patients with persistent AF. Epicardial adipose tissue (EAT) may play an
independent role in the progression, development and recurrence of AF after catheter ablation. Specifically, left
atrial (LA) EAT due to its contiguity to the LA may directly influence LA substrate via inflammatory, profibrotic,
and other adipocytokines. Liraglutide (a glucagon like peptide-1 analog), an effective therapy for obesity and
diabetes, markedly reduces EAT. A combined medical approach for substrate stabilization with catheter
ablation has not been evaluated. Thus, the overall goal of this project is to assess the novel approach of
substrate stabilization as adjunctive therapy in patients with persistent AF undergoing catheter ablation. We
hypothesize that Liraglutide treatment will significantly reduce LAEAT and consequently stabilize (and even
perhaps ameliorate) AF substrate. Our specific aims are to: 1) Assess for serial changes in LAEAT, EAT,
atrial size/function and biomarkers of inflammation in patients with persistent AF who opt for catheter
ablation due to Liraglutide treatment; 2) Evaluate the correlation of LAEAT to LA biomarkers. We will
enroll 60 patients with persistent AF who have elected to undergo catheter ablation. Pre-ablation therapy will
include: 1) antiarrhythmic drug therapy and cardioversion (if needed) to promote reverse electrical remodeling;
2) Risk factor management; 3) Half will be randomized to receive Liraglutide. After pre-treatment for 3 months,
catheter ablation will be performed using an antral pulmonary vein isolation based approach. The primary
endpoint will be change in LAEAT at 3 months (prior to ablation). Substrate evaluation will include CT (EAT,
LAEAT), echocardiography (strain, EAT thickness), and biomarkers at enrollment, pre-ablation, and at one
year. We will assess freedom from AF at one year off antiarrhythmic drugs documented by long-term event
monitoring and compare baseline LAEAT. Evaluating the broad array of imaging and blood biomarkers will
help delineate parameters that can be used to track substrate stabilization therapy. Thus, this open label
clinical study of Liraglutide in combination with catheter ablation for AF will provide foundational data that will
be critical for the further testing and validation of this nove...

## Key facts

- **NIH application ID:** 9868331
- **Project number:** 5R01HL145165-02
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** JEFFREY J GOLDBERGER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $650,635
- **Award type:** 5
- **Project period:** 2019-02-15 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9868331

## Citation

> US National Institutes of Health, RePORTER application 9868331, Novel medical adjunctive therapy to catheter ablation for atrial fibrillation (5R01HL145165-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9868331. Licensed CC0.

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