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Liraglutide Effect in Atrial Fibrillation
Plain-language guide to NCT03856632: phase 4 randomized trial of Liraglutide, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03856632
- Phase
- phase 4
- Status
- active, not recruiting
- Start
- 2019-03-18
- Completion (planned or actual)
- 2026-12-31
- Participants
- 60 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Atrial Fibrillation
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Liraglutide.
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.
This medication is known to work on fat deposits and produce weight loss.
It had two arms (groups): Risk Factor Modification (RFM) (active comparator) and RFM plus Liraglutide (experimental).
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 their 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.
The registry classes the interventions as drug, other and procedure.
Who Took Part
Enrollment: 60 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male and female, age 18 or older. BMI ≥27 kg/m2. Patient wishes to undergo a catheter ablation procedure for the treatment of atrial fibrillation.
The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: inability to sign an informed consent; patients with longstanding persistent atrial fibrillation of more than 3 years; prior ablation for atrial fibrillation.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.
It started in 2019-03-18 with completion listed for 2026-12-31.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change in size of Left Atrial Epicardial Adipose Tissue (LAEAT) (time frame: Baseline, 3 months (prior to ablation)).
It also tracked 9 secondary outcomes, for example Change in size of Epicardial Adipose Tissue (EAT) thickness, Change in atrial function, Change in atrial size, Change in C-Reactive Protein (CRP) value, Change in Interleukin-6 (IL-6) and Correlation of CRP expression in blood from left atrium to peripheral plasma.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Liraglutide in 60 people.
Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Liraglutide compound page, all human trials.
Our Notes on the Compound
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.