Emulation of the EMPEROR-Reduced Trial Using Healthcare Claims Data

Completed

Conditions studied: Heart Failure With Reduced Ejection Fraction, Chronic Heart Failure

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

NCT07599345

Run by

Brigham and Women's Hospital

People needed

23955

Starts

2024-10-13

Expected to finish

2026-06-15

Last updated by the study team

2026-07-10

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 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
• Implantable cardiac defibrillator
• Hypotension
• Major surgery
• GI surgery or disorder
• Cancer
• Heart transplant
• LVAD
• Liver disease
• Atrial fibrillation
• Hypertension
• Impaired renal function
• Anemia
• Ketoacidosis
• Pregnancy
• Ventricular arrhythmia
• Heart block
• Cardiomyopathy
• Valvular heart disease
• Chronic pulmonary disease
• Combined comorbidity score
• Chronic alcohol and or drug abuse
• Noncompliance
• Acute decompensated HF

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.