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Massive claims study aims to validate Real-World evidence for heart failure drugs

NCT ID NCT07599293

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study uses healthcare claims data from nearly 40,000 people to see if the results of a major clinical trial (EMPEROR-Preserved) can be reproduced in a real-world setting. Researchers are comparing two diabetes drugs, empagliflozin and sitagliptin, in patients with heart failure with preserved ejection fraction and type 2 diabetes. The goal is to learn when real-world data can be trusted to answer clinical questions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Empagliflozin and sitagliptin
What this could lead to
If successful, this could show that analyzing real-world data can reliably replace or supplement traditional clinical trials for certain questions.
What could go wrong
This is an observational study, not a controlled experiment, so results may be biased or not match the original trial. It cannot prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

39,614 people

The number who actually took part.

Started

Oct 2024

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals aged 18 years or older with heart failure and preserved ejection fraction and type 2 diabetes

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

congestive heart failure diastolic heart failure heart failure type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic heart failure Heart failure with preserved ejection fraction Type 2 diabetes mellitus

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.