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

NCT06914102 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58387

Last updated 2026-01-30

No results posted yet for this study

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

Conditions

  • Diabetes Mellitus, Type 2
  • HFpEF - Heart Failure With Preserved Ejection Fraction

Interventions

DRUG

Semaglutide

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Shirley Wang, PhD, ScM · Brigham and Women's Hospital

  • Nils Krüger, MD · Brigham and Women's Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-14
Primary Completion
2025-06-01
Completion
2025-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06914102 on ClinicalTrials.gov