Active — Not RecruitingNot Applicable

Comparative Effectiveness of Tirzepatide vs Semaglutide in Participants With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction

United States26,000 participantsStarted 2025-01-01

Plain-language summary

This cohort study aims to assess the comparative effectiveness of tirzepatide versus semaglutide with respect to cardiovascular events in patients with type 2 diabetes and heart failure with preserved ejection fraction.

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.

Inclusion Criteria: * Patients who are new users of tirzepatide or new users of semaglutide * Patients with diagnosis of T2D and HFpEF, i.e., EF \>= 45%. * Age \>= 18 years old * Patients with continuous health plan enrollment before and including the treatment initiation date Exclusion Criteria: * Patients with missing age or sex information * Patients with type 1 diabetes mellitus, secondary or gestational diabetes * History of diabetes related complications * Patients with related chronic diseases. * History of gastrointestinal conditions. * Previous exposure to other GLP-1RA and pramlintide * Patients with prescription dispensing for both tirzepatide and semaglutide on cohort entry date

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Hospitalization for heart failure and all-cause mortality

Timeframe: From treatment initiation to end of follow up, up to 48 months.

Trial details

NCT IDNCT06980623

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-30

View on ClinicalTrials.gov More Type 2 Diabetes trials

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.