Emulation of the STEP-HFpEF DM Heart Failure Trial in Healthcare Claims Data

NCT06914102 · Completed

Last updated 2026-05-28

This study used existing healthcare records to test the effects of a medication (similar to the one in the STEP-HFpEF DM trial) in adults with type 2 diabetes and heart failure with preserved ejection fraction.

Status Completed The study has finished.

Type Observational

Participants 58,387 people

Who can join Ages 18+ · all sexes

Timeline Started 2025-01 · est. completion 2025-06

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT06914102 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide Drug

New use of semaglutide dispensing claim is used as the exposure.
Placebo Drug

New use of sitagliptin dispensing claim is used as the reference (active-comparator proxy for placebo).

Main thing measured	Composite of all-cause mortality or heart failure hospitalization
Sponsor	Brigham and Women's Hospital
Conditions studied	Diabetes Mellitus, Type 2, HFpEF - Heart Failure With Preserved Ejection Fraction
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06914102 ↗