Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data

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.

Study period: Optum: Eligible cohort entry period from August 1, 2014 to August 31, 2024. Marketscan: Eligible cohort entry period from August 1, 2014 to September 31, 2023. Medicare: Eligible cohort entry period from August 1, 2014 to September 31, 2020. Inclusion Criteria: * 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 Exclusion Criteria: * 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