Emulation of the EMPEROR-Reduced Trial Using Healthcare Claims Data

NCT07599345 | Active Not Recruiting FDA Drug

• 2 other identifiers: 2018P002966-EMPERORReduced75F40122C00154
• Study Type: observational
• Target: 23,955
• 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

Chronic Heart Failure; Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

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

  To evaluate the comparative effect of empagliflozin versus sitagliptin on death and hospitalisation for heart failure in patients with chronic heart failure and reduced ejection fraction.

  1 day after cohort entry date until the first of outcome, disenrollment, end of study period, discontinuation (30 days grace and risk window), switch between the arms, start of any other SGLT2i or DPP4i

Secondary Outcomes (1)

• Cataract surgery

  1 day after cohort entry date until the first of outcome, disenrollment, end of study period, discontinuation (30 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 chronic heart failure and reduced ejection fraction

You may qualify if:

• At least 18 years of age
• Heart failure with reduced ejection fraction
• Type 2 diabetes mellitus
• Use of oral diuretics
• Use of appropriate medical therapy for HF

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 \[all available data, Day 0\]
• LVAD \[all available data, Day 0\]
• 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 \[Day -183, Day 0\]
• Ketoacidosis \[Day -183, Day 0\]

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Interventions

empagliflozin; Sitagliptin Phosphate

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)