Emulation of the EMPEROR-Reduced Trial Using Healthcare Claims Data

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07599345
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Initiation of empagliflozin described in electronic health records is used as the exposure.
  • Sitagliptin — DRUG
    Initiation of sitagliptin described in electronic health records is used as the reference.

Study Details

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.

Key Dates

Start date
Oct 13, 2024
Status verified
May 2026
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
23,955 participants (actual)

Arms

  • Arm: Empagliflozin
    Exposure group
  • Arm: Sitagliptin
    Reference group

Primary Outcome Measure

Time to first occurrence of hospitalization for heart failure or all-cause mortality [ Time Frame: From 1 day after entry through first occurrence of outcome, disenrollment, end of study period, treatment discontinuation +45-day grace/risk window, treatment switch, nursing home admission, or start of other SGLT2i or DPP4i, assessed up to 1 year. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

Find similar trials in Boston, MA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Brigham and Women's Hospital· Boston, MA

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