Clinical Trial: Type two diabetes mellitus and heart failure with preserved ejection fraction treated with tirzepatide effects on exercise capacity (Japan)

Tokyo, Nov. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063506) titled 'Type two diabetes mellitus and heart failure with preserved ejection fraction treated with tirzepatide effects on exercise capacity' on Nov. 4.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - St. Marianna University School of Medicine

Condition: Condition - Type two diabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To exploratorily evaluate the effects of tirzepatide, initiated as an approved treatment for type 2 diabetes mellitus, on exercise capacity in patients with type 2 diabetes mellitus and heart failure with preserved ejection fraction (HFpEF), compared with optimized standard diabetes care. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Tirzepatide Interventions/Control_2 - control

Eligibility: Age-lower limit - 20 years-old 45%, and clinical evidence of HFpEF based on hemodynamic, biomarker, echocardiographic, or hospitalization criteria. Key exclusion criteria - Patients with severe cardiac or systemic disease, current GLP-1/GIP agonist use, recent cardiovascular hospitalization, CPET contraindications, or other conditions deemed unsuitable. Target Size - 24

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 11 Month 04 Day Anticipated trial start date - 2026 Year 12 Month 10 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072673

Disclaimer: Curated by HT Syndication.