Emulation of the SUMMIT Heart Failure Trial in Healthcare Claims Data

NCT06914154 · Completed

Last updated 2026-05-28

This study tests whether a real-world healthcare data approach can replicate the findings of a clinical trial that examined the effects of a treatment on people with both type 2 diabetes and heart failure with preserved ejection fraction.

Status Completed The study has finished.

Type Observational

Participants 11,265 people

Who can join Ages 40+ · all sexes

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

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT06914154 ↗

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

Tirzepatide Drug

New use of tirzepatide 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 hospitalisation.
Sponsor	Brigham and Women's Hospital
Conditions studied	Diabetes Mellitus, Type 2, Heart Failure With Preserved Ejection Fraction (HFPEF)
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06914154 ↗