Clinical trial

Comparative Effectiveness of Oral Semaglutide vs Sitagliptin Among Individuals With Heart Failure With Preserved Ejection Fraction (STEP-HFpEF DM ORAL)

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07390110

Active, not recruitingNot applicableObservational

What this study is about

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 clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes, Heart Failure

Full registry criteria

Eligible Cohort Entry Dates: * Optum: Eligible cohort entry period from September 20, 2019 to November 30, 2025. * Marketscan: Eligible cohort entry from September 20, 2019 to December 31, 2023. * Medicare: Eligible cohort entry from September 20, 2019 to December 31, 2020. Inclusion Criteria: * Heart failure * BMI \> 27.0kg/m2 * Type 2 diabetes mellitus * LVEF \> 45% * Age \> 18 years * Sex: male or female Exclusion Criteria: * Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma, other malignancy * Type 1 diabetes mellitus, uncontrolled diabetic retinopathy or maculopathy, bariatric surgery, end-stage renal disease or dialysis, nursing home admission * Any use of GLP-1-RA including injectable semaglutide except oral semaglutide, pregnancy, treatment with continuous subcutaneous insulin infusion * Concurrent use of both study drugs

Treatments and study arms

Oral semaglutide

Drug

Initiation of semaglutide dispensing claim is used as the exposure.

Sitagliptin

Drug

Initiation of sitagliptin dispensing claim is used as the reference.

Primary outcomes

Composite of worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting) or all-cause mortality.Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between the arms, start of any other GLP-1-RA including injectable semaglutide.

To evaluate the comparative effect of oral semaglutide vs sitagliptin on the composite of worsening heart failure events or all-cause mortality in patients with heart failure with preserved ejection fraction in clinical practice.

Worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting).Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between the arms, start of any other GLP-1-RA including injectable semaglutide.

To evaluate the comparative effect of oral semaglutide vs sitagliptin on worsening heart failure events with heart failure with preserved ejection fraction in clinical practice.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States

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