Suspended

Tirzepatide vs Semaglutide for Type 2 Diabetes and Heart Failure with Preserved Ejection Fraction

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Cardiovascular Diseases+6

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2025
See protocol details

Summary

Principal SponsorBrigham and Women's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2025

Actual date on which the first participant was enrolled.

This study is designed to compare the effectiveness of two medications, tirzepatide and semaglutide, in adults with type 2 diabetes and a specific type of heart failure known as heart failure with preserved ejection fraction (HFpEF). Both medications are already approved for controlling blood sugar levels and aiding weight loss in people with type 2 diabetes and obesity. Obesity is a major risk factor for developing heart failure, particularly HFpEF. By understanding how these drugs work in people with type 2 diabetes and HFpEF, the study aims to improve treatment strategies and possibly reduce symptoms and events related to heart failure. Participants in this study are adults over 18 years old who have type 2 diabetes and HFpEF and have recently started taking either tirzepatide or semaglutide. Researchers will collect information about participants from insurance records, including their medical history and treatment details. The study will track participants from the day after they begin their medication until certain events occur, such as hospitalization due to heart failure or death from any cause. The study will analyze results using statistical methods to understand the risk and benefits of each medication, focusing on how they impact heart failure-related hospitalizations and overall survival.

Official TitleComparative Effectiveness of Tirzepatide vs Semaglutide in Participants With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction
NCT06980623
Principal SponsorBrigham and Women's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHeart DiseasesHeart FailureMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Brigham and Women's Hospital

Boston, United StatesOpen Brigham and Women's Hospital in Google Maps
SuspendedOne Study Center