Status:
ACTIVE_NOT_RECRUITING
Comparative Effectiveness of Tirzepatide Versus Semaglutide in Individuals With Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Diabetes Mellitus, Type 2
HFpEF - Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
18+ years
Brief Summary
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clin...
Detailed Description
This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT...
Eligibility Criteria
Inclusion
- Eligible cohort entry dates:
- Optum: Study period between May 13, 2022 to November 30, 2024. Marketscan: Study period between May 13, 2022 to December 31, 2023.
- Heart failure
- BMI \> 27.0 kg/m2
- History of type 2 diabetes mellitus
- LVEF ≥ 45%
- ≥ 18 years old, male or female sex
Exclusion
- Prior treatment with any GLP-1-RA
- History of type 1 diabetes mellitus
- End-stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis
- History of bariatric surgery
- History of nursing home admission
- Pregnant female or breastfeeding
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
- Treatment with continuous subcutaneous insulin infusion
- Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) for less than 5 years
Key Trial Info
Start Date :
January 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
28118 Patients enrolled
Trial Details
Trial ID
NCT06914141
Start Date
January 14 2025
End Date
May 1 2025
Last Update
May 22 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120