TIRO-AF: TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation
This is a single center randomized double blind controlled study of patients (BMI\> 30 kg/m2) with obesity and Atrial Fibrillation (AFIB) randomized to Tirzepatide vs. placebo. It is expected that the significant weight loss with Tirzepatide will result in improved control, management, symptom severity, and burden of AFIB at 12 months.
∙ Subjects eligible for inclusion in this study must meet all of the following criteria:
• Sinus rhythm at randomization
‣ Sustained normal sinus rhythm (or)
⁃ Normal sinus rhythm at office visit
• Age ≥18 to ≤80 years old
• BMI \>30 and ≤60 kg/m2
• AFIB criteria:
‣ Must be documented by ECG or monitor.
⁃ Must have symptomatic AFIB (Atrial Fibrillation).
⁃ In terms of types of AFIB, either paroxysmal AFIB or persistent AFIB.
• All anti-diabetic medication (including insulin) must be stable for at least 3 months prior to enrollment,
• HbA1c ≤10% for patients diagnosed with Type 2 Diabetes Mellitus (T2DM).
• Ability and willingness to give themselves the medication, comply with study requirements and provide written informed consent.