Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data

NCT07599293 | Active Not Recruiting 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)

• A composite of hospitalization for heart failure or all-cause mortality

  To evaluate the comparative effect of empagliflozin vs sitagliptin on hospitalisation for heart failure or all-cause mortality in patients with heart failure and preserved ejection fraction.

  1 day after cohort entry date 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 SGLT2i or DPP4i.

Secondary Outcomes (3)

• Cataract surgery

  1 day after cohort entry date 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 SGLT2i or DPP4i.

• Lumbar radiculopathy

  day after cohort entry date 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 SGLT2i or DPP4i.

• Hernia

  1 day after cohort entry date 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 SGLT2i or DPP4i.

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 \[Day -91, Day 0\]
• Implantable cardiac defibrillator \[Day -91, Day 0\]
• Hypotension \[Day -91, Day 0\]
• Major surgery \[Day -91, Day 0\]
• GI surgery or disorder \[Day -91, Day 0\]
• Cancer \[Day -730, Day 0\]
• Heart transplant \[all available data, Day 0\]
• Pacemaker \[all available data, Day 0\]
• Liver disease \[all available data, Day 0\]
• Atrial fibrillation \[Day -183, Day 0\]
• Hypertension \[Day -183, Day 0\]
• Impaired renal function \[Day -183, Day 0\]
• Anemia \[Day -183, Day 0\]
• History of ketoacidosis \[Day -183, Day 0\]

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 (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

US (1)