A randomized controlled trial on the effect of semaglutide on cardiovascular outcomes in patients with chronic heart failure with preserved ejection fraction and type 2 diabetes mellitus

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: control group:standard of care for HFpEF;Experimental group:Semaglutide plus standard of care for HFpEF; CONDITION: patients with chronic heart failure with preserved ejection fraction and type 2 diabetes mellitus PRIMARY OUTCOME: Composite endpoints (cardiovascular death or hospitalization for heart failure); SECONDARY OUTCOME: Cardiac structure and function;Cardiovascular death;Safety of semaglutide;Heart failure rehospitalization;Quality of life (as assessed by the KCCQ score);All‐cause mortality; INCLUSION CRITERIA: 1. Age >=45 years and <=85 years; 2. Confirmed diagnosis of type 2 diabetes mellitus (according to ADA criteria), currently receiving at least one glucose‐lowering therapy; 3. Confirmed diagnosis of chronic heart failure with preserved ejection fraction (according to ESC 2023 guidelines): signs/symptoms of heart failure (NYHA class II–IV); LVEF >=50%; elevated natriuretic peptides (BNP >=35 pg/mL or NT‐proBNP >=125 pg/mL); evidence of structural/functional cardiac abnormalities (left atrial enlargement, left ventricular hypertrophy, or diastolic dysfunction); 4. Clinically stable (no hospitalization for heart failure within the past 4 weeks).
Epistemonikos ID: 845cc4891fce9627bc9e9f9c7fb4ab7f6468c0a9
First added on: Oct 08, 2026