Active — Not RecruitingNot Applicable

Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data

United States39,614 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.

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

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 seems to be analyzing existing insurance claims data rather than enrolling patients in a new treatment — can you explain what that means for me, and whether there's any direct benefit or risk to me from this kind of records-based research?
2The original EMPEROR-Preserved trial looked at empagliflozin for heart failure with preserved ejection fraction — is that medication something that might already be appropriate for my situation, given that I have both heart failure with preserved ejection fraction and type 2 diabetes?
3Since this trial is listed as 'active but not recruiting,' it sounds like they're not signing up new participants — does that mean the findings might be available soon, and would it be worth waiting to see what this study shows before we finalize my treatment plan?
4The study is tracking hospitalization for heart failure and all-cause mortality as its main outcomes — based on where I am right now, how does my personal risk for those outcomes compare, and how does that affect which treatment path you'd recommend for me?
5Since this is a Phase NA observational study using claims data rather than a controlled drug trial, how confident can we be in whatever results it produces, and are there other completed trials or current standard-of-care options you think are more directly relevant to my case?

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 IDNCT07599293

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-19

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