Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data

NCT07599293 | Completed FDA Drug

• 1 other identifier: 2018P002966-EMPERORPreserved
• Study Type: observational
• Target: 39,614
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure With Preserved Ejection Fraction; Chronic Heart Failure; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Time to first occurrence of hospitalization for heart failure or all-cause mortality

  The primary outcome is the time from 1 day after cohort entry to the first occurrence of either component of the composite endpoint: hospitalization for heart failure or all-cause mortality, comparing empagliflozin versus sitagliptin in patients with heart failure and preserved ejection fraction.

  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.

Secondary Outcomes (3)

• Time to first occurrence of cataract surgery

  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.

• Time to first occurrence of lumbar radiculopathy

  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.

• Time to first occurrence of hernia

  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.

Study Arms (2)

Empagliflozin

Exposure group

Drug: Empagliflozin

Sitagliptin

Reference group

Drug: Sitagliptin

Interventions

Empagliflozin DRUG

Initiation of empagliflozin described in electronic health records is used as the exposure.

Empagliflozin

Sitagliptin DRUG

Initiation of sitagliptin described in electronic health records is used as the reference.

Sitagliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 18 years or older with heart failure and preserved ejection fraction and type 2 diabetes

You may qualify if:

• At least 18 years of age
• Heart failure with preserved ejection fraction
• Structural heart disease
• Previous HHF
• BMI \< 45 kg/m2
• Type 2 diabetes mellitus
• Use of oral diuretics

You may not qualify if:

• Concurrent use of both study drugs on cohort entry date
• MI, CABG or other major cardiovascular surgery, GI surgery or disorder, stroke or TIA
• Implantable cardiac defibrillator
• Hypotension
• Major surgery
• GI surgery or disorder
• Cancer
• Heart transplant
• Pacemaker
• Liver disease
• Atrial fibrillation
• Hypertension
• Impaired renal function
• Anemia
• History of ketoacidosis

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: October 13, 2024
• Primary Completion: June 19, 2026
• Study Completion: June 19, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

US (1)