Study S000347

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

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT06914102
Acronym: DUP-STEP-HFpEF
Study type: OBSERVATIONAL
Status: COMPLETED
Enrollment: 58387
Start: 2025-01-14
Primary completion: 2025-06-01
Lead sponsor: Brigham and Women's Hospital
Conditions: Diabetes Mellitus, Type 2; HFpEF - Heart Failure With Preserved Ejection Fraction
Interventions: DRUG:Semaglutide; DRUG:Placebo
Results posted: FALSE

Registered primary outcomes

Composite of all-cause mortality or heart failure hospitalization [Through study completion (1 day after cohort entry date until the first of outcome or censoring)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0009707	Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction. Krüger N, JAMA	2025	Nonrandomized study	PMID 40886075 DOI	cites ClinicalTrials.gov:NCT06914102; registry reference DERIVED:40886075