None listed
Conditions
Brief summary
Heart failure with preserved ejection fraction (HFpEF) is the most common type of heart disease, especially in people living with obesity. It causes symptoms of heart failure despite normal pumping function and is linked to changes in heart pressure and scarring of the heart muscle. However, we know if these changes can be reversed through weight loss, or whether different weight loss methods-such as medication or surgery-have different effects. This project will compare two approaches to weight loss in people with obesity and HFpEF: a new injectable medication called tirzepatide and a standard care with an exercise program. We will utilise advanced heart scans (MRI and metabolic imaging), exercise tests, blood tests, and invasive heart pressure monitoring before and after one year of treatment to assess the impact of each method on heart structure, function, and symptoms. We expect to show that significant weight loss improves heart function, reduces scarring, and relieves symptoms. This could lead to larger studies and eventually help reduce hospital stays, medication use, and healthcare costs.
Interventions
Intervention group will receive tirzepatide (Eli Lilly)- titrated as per manufacturer's guidelines until the maximum dose (or tolerated dose) of 15mg weekly subcutaneous injection for 12-months. Starting at 2.5mg weekly, increasing by 2.5mg increments every 4 weeks until the maximum dose (15mg) is achieved.
There are no laboratory tests that monitor adherence to this medication.
Intervention group will receive a weekly subcutaneous dose of tirzepatide (Eli Lilly) with incremental dose increases up to 15mg as per prescribing guidelines for twelve months (starting at 2.5mg weekly, increasing by 2.5mg increments every 4 weeks until the maximum tolerated dose is achieved or 15mg), as well as usual care (a personalised exercise program with exercise physiologist, regular consultation in a HFpEF clinic and prescription of an SGLT-2 inhibitor, if appropriate). There are no lab
Intervention group will receive a weekly subcutaneous dose of tirzepatide (Eli Lilly) with incremental dose increases up to 15mg as per prescribing guidelines for twelve months (starting at 2.5mg weekly, increasing by 2.5mg increments every 4 weeks until the maximum tolerated dose is achieved or 15mg), as well as usual care (a personalised exercise program with exercise physiologist, regular consultation in a HFpEF clinic and prescription of an SGLT-2 inhibitor, if appropriate). There are no laboratory tests that monitor adherence to this medication.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
• Are greater than 18 years old, • Have a BMI of 30 or more, or a BMI of 27 or more and at least one weight-related complication (e.g., hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease), • Report one or more unsuccessful dietary effort to lose weight.
Exclusion criteria
• Diabetes • Change in body weight of more than 5 kg within 90 days before screening • Previous or planned surgical treatment for obesity • Treatment with a medication that promotes weight loss within 90 days before screening • Ejection fraction <50% (current or prior) • Pregnancy • Significant valvular heart disease (greater than mild stenosis, greater than moderate regurgitation) • Pulmonary arterial hypertension • Constrictive pericarditis • Primary cardiomyopathies • Heart transplantation • Significant pulmonary disease • History of pancreatitis • Previous bariatric surgery • Diagnosis of gastroparesis • Diagnosis of cancer within the past 5 years (excluding skin cancers) • Personal or family history of medullary thyroid cancer • Patients not eligible for Medicare • Patients who are not fluent in English.
Outcome results
None listed