IRB Study Number 24-228
Status Recruiting
Location J Building - Sydell and Arnold Miller Family Pavilion
Institute Heart and Vascular Institute
Description
The purpose of this study is to examine the effect of tirzepatide on weight loss and burden of severity of symptoms of atrial fibrillation. . This study is being conducted for subjects that have atrial fibrillation and have recently had a cardioversion (treatment using low-energy shock to restore normal heart rhythm). The subjects in this study are randomly selected (like flip of a coin) for either tizepatide or placebo (looks like the study drug but contains no active ingredients). Both the physician and subject will be blinded to which treatment will be assigned. The follow up period will be 53 weeks after randomization. All subjects will receive standard care for management of risk factors. Management of atrial fibrillation including anti-arrhythmic medications, ablation and cardioversion is at the discretion of Cleveland Clinic Cardiologists. Tirzepatide has been approved by the US Food and Drug Administration (FDA) in addition to a reduced- calorie diet and increased physical activity for chronic weight management in adults. This research may benefit future patients with obesity and atrial fibrillation.
Inclusion Criteria
Eligible subjects must meet all of the following:
- Age 18 yrs. to 80 yrs. old
- Sinus rhythm at enrollment (sustaining normal sinus rhythm for 2 hours post cardioversion)
- BMI over 30
- Ability to give self-injections of medication, comply with study requirements and provide written informed consent
- HbA1c less than 10% for patients with Type 2 Diabetes Mellitus
- All anti- diabetic medication (including insulin) must be stable for at least 3 months prior to enrollment
- Atrial fibrillation criteria
- documented by EKG or monitor
- must have symptomatic atrial fibrillation
- Persistent or Paroxysmal types of atrial fibrillation
Exclusion Criteria
Subjects meeting any of the following are not eligible for inclusion in this study:
- Atrial Fibrillation Ablation procedure completed within 6 months
- planned ablation prior to 3 months post randomization
- Significant cardiac valvular disease with planned cardiac valve intervention/ surgery in next 12 months
- Severe uncompensated cardiopulmonary disease
- New York Heart Association Class III or IV
- Left ventricular ejection fraction of 35% or lower at time of screening
- Hospitalization within the las 6 months for MI- Myocardial infarction, unstable angina, stroke, TIA, or heart surgery
- History of solid organ transplant
- Type 1 diabetes mellitus or auto -immune diabetes
- eGFR less than 30mL/min/1.73m² at screening, or on dialysis treatment
- Advanced and decompensated cirrhosis characterized by presence of fibrosis stage 4 in liver biopsy, ascites, hepatic encephalopathy, portal hypertension, or esophageal varices
- Hemoglobin less than 9g/dL
- Current participation or current use of investigational therapy or less than 3 months since participation of any drug or device trial
- Liver transaminase level greater than 300 U/L
- Subject reports alcohol use of over 2 drinks per day on average
- Presence of active malignancy (except non- melanoma skin cancer)
- Life expectancy less than 3 years due to concomitant diseases
- Major mental health, psychological disorders, or substance abuse disorders that could disqualify the patient from metabolic surgery
- Any condition or illness that, in the investigator's judgement, places the subject at undue risk by participating in the study
- Plans to move outside the location of the study (Northeast Ohio) within the next 12 months
- Any personal or family history of pancreatitis or medullary thyroid cancer or MENS2
- Current use or any use within the last 6 months of GLP-1/DPP4i or GIP/GLP-1
- Known sensitivity to IP due to prior use of GLP-1/DPP4i or GIP/GLP-1
- Allergy to medical grade tape or adhesive
- Pregnant, breast feeding or plans to become pregnant
