Comparative Effectiveness of Oral Semaglutide vs Sitagliptin Among Individuals With Heart Failure With Preserved Ejection Fraction (STEP-HFpEF DM ORAL)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07390110
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Oral semaglutide — DRUG
    Initiation of semaglutide dispensing claim is used as the exposure.
  • Sitagliptin — DRUG
    Initiation of sitagliptin dispensing claim 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
Jan 24, 2026
Status verified
Jan 2026
Primary completion
May 30, 2026
Completion
May 30, 2026

Study Design

Enrollment
25,664 participants (actual)

Arms

  • Arm: Initiation of oral semaglutide
    Exposure group: Semaglutide in the oral formulation in any dose.
  • Arm: Initiation of sitagliptin
    Reference group: Sitagliptin in the oral formulation in any dose

Primary Outcome Measure

Composite of worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting) or all-cause mortality. [ Time Frame: Through study completion until the first of outcome, disenrollment, end of study period, discontinuation (45 days grace and risk window), switch between the arms, start of any other GLP-1-RA including injectable semaglutide. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

Find similar trials in Boston, MA

By condition
Heart failureType 2 diabetes
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Brigham and Women's Hospital· Boston, MA

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