Active — Not RecruitingNot Applicable

Emulation of the EMPEROR-Reduced Trial Using Healthcare Claims Data

United States23,955 participantsStarted 2024-10-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Optum: Study period between 1st August 2014 - 31st December 2024. Marketscan: Study period between 1st August 2014 - 30th September 2022. Medicare: Study period between 1st August 2014 - 30th September 2022. Inclusion Criteria: * 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 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 * 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 * Use of SGLT2i or DPP4i

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is described as an 'emulation' of a prior trial using insurance claims data rather than enrolling new patients — does that mean my personal care wouldn't change at all if this study is relevant to my situation, and what does that type of research actually tell us about treating heart failure with reduced ejection fraction?
2Since this study is actively analyzing data but no longer recruiting participants, are the findings expected to be published soon, and could those results influence the treatment options you'd recommend for my chronic heart failure?
3The main thing this study is measuring is the time until a first hospitalization for heart failure or death from any cause — based on what's already known from the original EMPEROR-Reduced trial, how do the treatments being compared here fit into what you'd consider for my care right now?
4Because this is a claims-data study with no assigned phase, it isn't testing safety or dosing the way a Phase 1 or 2 trial would — does that mean the treatments involved are already FDA-approved, and should I be asking about accessing them outside of a trial altogether?
5Would the real-world insurance claims evidence this study is generating change your thinking about heart failure treatment compared to the original controlled trial results, and is that something worth waiting on before we finalize my treatment plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to first occurrence of hospitalization for heart failure or all-cause mortality

Timeframe: From 1 day after entry through first occurrence of outcome, disenrollment, end of study period, treatment discontinuation +45-day grace/risk window, treatment switch, nursing home admission, or start of other SGLT2i or DPP4i, assessed up to 1 year.

Trial details

NCT IDNCT07599345

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-15

View on ClinicalTrials.gov More Heart Failure With Reduced Ejection Fraction trials