Emulation of the SUMMIT Heart Failure Trial in Healthcare Claims Data

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06914154
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 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).

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
Jan 14, 2025
Status verified
May 2025
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
11,265 participants (actual)

Arms

  • Arm: Tirzepatide
    Exposure group
  • Arm: Placebo
    Reference group

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

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