Study S000047
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)
Included trial: extracted dataClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)
Registration
Registered primary outcomes
- Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) [Baseline, Week 52]
- First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes [Baseline Up To 160 weeks]
Linked records (10)
Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
| Record | Title | Year | Design | Identifiers | Link basis |
|---|---|---|---|---|---|
| R0004331 | Effects of Tirzepatide in Obesity-Related HFpEF by Sex: A Prespecified Secondary Analysis From the SUMMIT Trial. Borlaug BA, JACC. Heart failure | 2026 | Randomized trial | PMID 42417681DOI | cites ClinicalTrials.gov:NCT04847557; registry reference DERIVED:42417681 |
| R0006315 | Impact of Body Mass Index, Central Adiposity, and Weight Loss on the Benefits of Tirzepatide in HFpEF: The SUMMIT Trial. Borlaug BA, Journal of the American College of Cardiology | 2025 | Randomized trial | PMID 40701669DOI | cites ClinicalTrials.gov:NCT04847557; registry reference DERIVED:40701669 |
| R0007077 | Effects of tirzepatide on circulatory overload and end-organ damage in heart failure with preserved ejection fraction and obesity: a secondary analysis of the SUMMIT trial. Borlaug BA, Nature medicine | 2025 | Randomized trial | PMID 39551891DOI | cites ClinicalTrials.gov:NCT04847557; registry reference DERIVED:39551891 |
| R0008687 | Influence of Type 2 Diabetes on the Effects of Tirzepatide in Patients With Heart Failure and a Preserved Ejection Fraction With Obesity: A Prespecified Stratification-Based Analysis. Packer M, Journal of the American College of Cardiology | 2025 | Randomized trial | PMID 40903131DOI | cites ClinicalTrials.gov:NCT04847557; registry reference DERIVED:40903131 |
| R0013432 | Interplay of Chronic Kidney Disease and the Effects of Tirzepatide in Patients With Heart Failure, Preserved Ejection Fraction, and Obesity: The SUMMIT Trial. Packer M, Journal of the American College of Cardiology | 2025 | Randomized trial | PMID 40162940DOI | cites ClinicalTrials.gov:NCT04847557; registry reference DERIVED:40162940 |
| R0014557 | Tirzepatide Reduces LV Mass and Paracardiac Adipose Tissue in Obesity-Related Heart Failure: SUMMIT CMR Substudy. Kramer CM, Journal of the American College of Cardiology | 2025 | Other trial | PMID 39566869DOI | cites ClinicalTrials.gov:NCT04847557; registry reference DERIVED:39566869 |
| R0017742 | Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity. Packer M, The New England journal of medicine | 2025 | Randomized trial | PMID 39555826DOI | cites ClinicalTrials.gov:NCT04847557; registry reference DERIVED:39555826 |
| R0018803 | Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity. Zile MR, Circulation | 2025 | Randomized trial | PMID 39556714DOI | cites ClinicalTrials.gov:NCT04847557; registry reference DERIVED:39556714 |
| R0036245 | Recent Developments in Tirzepatide's Role in Reducing Cardiovascular Disease Risk Factors in Adults with Type 2 Diabetes Jones, Talaya, NSUWorks (Nova Southeastern University) | 2024 | Other trial | cites ClinicalTrials.gov:NCT04847557 | |
| R0052993 | No such thing as an innocent bystander: the conundrum of obesity, diabetes, and heart failure with preserved ejection fraction Petar M Seferovic, European Journal of Preventive Cardiology | 2023 | Randomized trial | PMID 37421379DOI | cites ClinicalTrials.gov:NCT04847557 |