The effect of substantial weight loss with tirzepatide on heart failure with preserved ejection fraction in people with obesity

Phase 4

• Conditions: Obesity; Heart Failure; Cardiovascular - Other cardiovascular diseases; Diet and Nutrition - Obesity

• Registration Number: ACTRN12624000270516
• Lead Sponsor: Baker Heart and Diabetes Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-18
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified