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Trial · Observational

CompletedPhase not statedRegistry data

Comparative Effectiveness of Tirzepatide Versus Semaglutide in Individuals With Heart Failure With Preserved Ejection Fraction

Short name DUP-TIRZSEMA

NCTNCT06914141 (opens ClinicalTrials.gov in a new tab)Other id2018P002966-DUP-TIRZSEMA
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
28,118 participants (actual)
Sponsor
Brigham and Women's Hospital · Other
Design
Not stated
Countries
1 country

United States

Start
14 Jan 2025
Primary completion
1 Jun 2025
Completion
1 Jun 2025
First posted
6 Apr 2025
Last update posted
30 Jan 2026
Conditions
Diabetes Mellitus, Type 2 · HFpEF - Heart Failure With Preserved Ejection Fraction

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026
  1. Ph –

    DUP-TIRZSEMA

    NCT06914141

    14 Jan 2025 to 1 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • SemaglutideDrug

Arms2

  • Other

    Tirzepatide

    New use of tirzepatide dispensing claim is used as the exposure.

  • Other

    Semaglutide

    New use of semaglutide dispensing claim is used as the reference.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Composite of all-cause mortality or heart failure hospitalization

    Time frame · Through study completion (1 day after cohort entry date until the first of outcome or censoring)

    Registry description

    To evaluate the comparative effect of tirzepatide vs semaglutide on all-cause mortality or heart failure hospitalization in patients with heart failure with preserved ejection fraction.

Secondary outcomes(8)

  1. Composite of all-cause mortality or all-cause mortality or a worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting).

    Time frame · Through study completion (1 day after cohort entry date until the first of outcome or censoring)

    Registry description

    To evaluate the comparative effect of tirzepatide vs semaglutide on all-cause mortality or worsening heart failure events in patients with heart failure with preserved ejection fraction.

  2. Worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization or intravenous diuretic therapy in an urgent care setting).

    Time frame · Through study completion (1 day after cohort entry date until the first of outcome or censoring)

    Registry description

    To evaluate the comparative effect of tirzepatide vs semaglutide on worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization or intravenous diuretic therapy in an urgent care setting) in patients with heart failure with preserved ejection fraction.

  3. Intravenous diuretic therapy in an urgent care setting

    Time frame · Through study completion (1 day after cohort entry date until the first of outcome or censoring)

    Registry description

    To evaluate the comparative effect of tirzepatide vs semaglutide on intravenous diuretic therapy in an urgent care setting in patients with heart failure with preserved ejection fraction.

  4. Hospitalization for heart failure

    Time frame · Through study completion (1 day after cohort entry date until the first of outcome or censoring)

    Registry description

    To evaluate the comparative effect of tirzepatide vs semaglutide on hospitalization for heart failure in patients with heart failure with preserved ejection fraction.

  5. All-cause mortality

    Time frame · Through study completion (1 day after cohort entry date until the first of outcome or censoring)

    Registry description

    To evaluate the comparative effect of tirzepatide vs semaglutide on all-cause mortality in patients with heart failure with preserved ejection fraction.

  6. Urinary tract infection

    Time frame · Through study completion (1 day after cohort entry date until the first of outcome or censoring)

    Registry description

    To evaluate the comparative effect of tirzepatide vs semaglutide on urinary tract infection in patients with heart failure with preserved ejection fraction.

  7. Serious bacterial infection

    Time frame · Through study completion (1 day after cohort entry date until the first of outcome or censoring)

    Registry description

    To evaluate the comparative effect of tirzepatide vs semaglutide on serious bacterial infection in patients with heart failure with preserved ejection fraction.

  8. Gastrointestinal adverse events

    Time frame · Through study completion (1 day after cohort entry date until the first of outcome or censoring)

    Registry description

    To evaluate the comparative effect of tirzepatide vs semaglutide on gastrointestinal adverse events in patients with heart failure with preserved ejection fraction.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 2025

5 results

Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction.

Krüger et al. 2025JAMAcited by 43

PMID 40886075PMC12400167DOI 10.1001/jama.2025.14092PUB-40886075

Rights unknown5 results
Source linkSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Eligible cohort entry dates: Optum: Study period between May 13, 2022 to November 30, 2024. Marketscan: Study period between May 13, 2022 to December 31, 2023. Inclusion Criteria: * Heart failure * BMI \> 27.0 kg/m2 * History of type 2 diabetes mellitus * LVEF ≥ 45% * ≥ 18 years old, male or female sex Exclusion Criteria: * Prior treatment with any GLP-1-RA * History of type 1 diabetes mellitus * End-stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis * History of bariatric surgery * History of nursing home admission * Pregnant female or breastfeeding * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy * Treatment with continuous subcutaneous insulin infusion * Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) for less than 5 years

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