The Cleveland Clinic
This is a single center randomized double blind controlled study of patients (BMI ≥ 27 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.
It is estimated that 12 million people in the United States will have AFIB by 2030. The obesity epidemic and all its comorbidities such as hypertension, diabetes and sleep apnea are potent risk factors for AFIB. Weight loss has emerged as a potent treatment for AFIB. This will be a randomized double blind controlled study of patients (BMI≥ 27 kg/m2) with obesity and AFIB randomized to Tirzepatide vs. placebo in the Cleveland Clinic Health System. It is expected that the weight loss with Tirzepatide will result in improved control, management, symptom severity, and burden of AFIB at 12 months.…
Inclusion Criteria: Subjects eligible for inclusion in this study must meet all of the following criteria: 1. Sinus rhythm at randomization 1. Sustained normal sinus rhythm (or) 2. Normal sinus rhythm at office visit 2. Age ≥18 to ≤80 years old 3. BMI ≥ 27 and ≤60 kg/m2 4. AFIB criteria: 1. Must be documented by ECG or monitor. 2. Must have symptomatic AFIB (Atrial Fibrillation). 3. In terms of types of AFIB, either paroxysmal AFIB or persistent AFIB. 5. All anti-diabetic medication (including insulin) must be stable for at least 3 months prior to enrollment, 6. HbA1c ≤10% f…
Weekly subcutaneous injections starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week12 (10mg) as tolerated.
Weekly subcutaneous injections starting with dose 2.5mg, then increase dose by 2.5mg at week 4 (5mg), week 8 (7.5mg) and at week 12 (10mg).
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