Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data

Completed

Conditions studied: Heart Failure With Preserved Ejection Fraction, Chronic Heart Failure, Type 2 Diabetes Mellitus

In brief

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 facts

Study ID

NCT07599293

Run by

Brigham and Women's Hospital

People needed

39614

Starts

2024-10-13

Expected to finish

2026-06-19

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Pregnancy
• Cardiomyopathy
• Valvular heart disease
• Chronic pulmonary disease
• Combined comorbidity score
• Chronic alcohol and or drug abuse
• Noncompliance
• Acute decompensated HF
• Use of SGLT2i or DPP4i

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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