Study S000913

Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity: A Double-Blinded Randomized Controlled Trial

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT07738276
Acronym: DUAL-HFrEF
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: NOT_YET_RECRUITING
Enrollment: 60
Start: 2026-07-18
Primary completion: 2027-06-11
Lead sponsor: Shahid Beheshti University of Medical Sciences
Conditions: Heart Failure and Reduced Ejection Fraction; Obesity & Overweight; Tirzepatide
Interventions: DRUG:Tirzepatide; DRUG:Placebo
Results posted: FALSE

Registered primary outcomes

Change in 6-Minute Walk Distance [Baseline and 6 months after intervention start]

Linked records (8)

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
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 39551891 DOI	registry reference BACKGROUND:39551891
R0017742	Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity. Packer M, The New England journal of medicine	2025	Randomized trial	PMID 39555826 DOI	registry reference BACKGROUND: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 39556714 DOI	registry reference BACKGROUND:39556714
R0004339	Glucagon-like peptide-1 receptor agonists use and associations with outcomes in heart failure and type 2 diabetes: data from the Swedish Heart Failure and Swedish National Diabetes Registries. Wallner M, European heart journal. Cardiovascular pharmacotherapy	2024	Nonrandomized study	PMID 38632048 DOI	registry reference BACKGROUND:38632048
R0007916	Semaglutide and NT-proBNP in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program. Petrie MC, Journal of the American College of Cardiology	2024	Randomized trial	PMID 38819334 DOI	registry reference BACKGROUND:38819334
R0019504	Tirzepatide reduces the predicted risk of atherosclerotic cardiovascular disease and improves cardiometabolic risk factors in adults with obesity or overweight: SURMOUNT-1 post hoc analysis. Hankosky ER, Diabetes, obesity & metabolism	2024	Randomized trial	PMID 37932236 DOI	registry reference BACKGROUND:37932236
R0020409	Effects of Semaglutide on Symptoms, Function, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction and Obesity: A Prespecified Analysis of the STEP-HFpEF Trial. Kosiborod MN, Circulation	2024	Randomized trial	PMID 37952180 DOI	registry reference BACKGROUND:37952180
R0020837	Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. Kosiborod MN, The New England journal of medicine	2023	Randomized trial	PMID 37622681 DOI	registry reference BACKGROUND:37622681