Evaluating the safety and efficacy of glimepiride in patients with type 2 diabetes and chronic heart failure with reduced ejection fraction--a multicenter randomized controlled study.
Age between 18 and 80 years old at the time of enrollment; gender is not restricted.
Patients diagnosed with type 2 diabetes according to the "Chinese Diabetes Prevention and Management Guidelines (2024 Edition)" issued by the Chinese Medical Association Diabetes Branch, with a confirmed diagnosis at least three months prior.
According to the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure (2024 Edition)" issued by the Chinese Society of Cardiology, the diagnosis is heart failure with reduced ejection fraction (HFrEF) or heart failure with mildly reduced ejection fraction (HFmrEF), confirmed at least three months prior.
NYHA heart failure classification stage II-IV;
Heart failure caused by valvular disease, congenital heart conditions, pericardial diseases, arrhythmias, or non-cardiogenic illnesses; as well as heart failure resulting from failure of vital organs such as renal or hepatic failure; and right-sided heart failure due to pulmonary origin or other definitive causes.
Currently experiencing acute decompensated heart failure (ADHF) or hospitalized for ADHF within the previous four weeks before enrollment.
Patients scheduled to undergo coronary artery revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or cardiac resynchronization therapy following randomization, or who have received cardiac resynchronization therapy within 12 weeks prior to enrollment.
Any conditions other than cardiovascular diseases, including but not limited to malignancies with an expected survival of less than three years, severe mental disorders, hematologic diseases, neuroendocrine disorders, elevated liver transaminases and alkaline phosphatase levels exceeding three times the upper limit of normal (ULN), renal impairment indicated by serum creatinine greater than 2 mg/dL (176.82 µmol/L), and hyperkalemia with serum potassium levels exceeding 5.5 mmol/L.
Parallel
Glimepiride (oral)
DrugStandardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral glimepiride (initial oral dose is 2 mg once daily. After 4 weeks, adjust the oral dose based on glycemic control and tolerability: If glycemic control is adequate, maintain the initial oral dose. If glycemic control is inadequate, modify the oral dose to 4 mg once daily.)
Placebo
DrugStandardized treatment for chronic heart failure + standardized treatment for type 2 diabetes + oral placebo (equivalent placebo administered according to the same regimen)
A composite endpoint of cardiovascular death, heart transplantation, or worsening heart failure (defined as rehospitalization for heart failure or an emergency heart failure visit requiring intravenous therapy).
The Primary Outcome is defined as a composite endpoint consisting of the time to the first occurrence of any of the following events: 1. Cardiovascular death is defined as any death due to a direct cardiovascular cause. 2. Heart transplantation is defined as receiving an allogeneic in situ heart transplant due to end-stage heart failure. The event date is defined as the date of surgery. 3. Heart failure exacerbation is defined as requiring intensive treatment due to worsening symptoms and signs of heart failure, meeting any of the following criteria: ① readmission for heart failure; ② urgent heart failure visit requiring intravenous therapy.
All-cause mortality rate
Death occurring during the study period for any cause. This is the most objective and unbiased endpoint. All deaths, whether cardiovascular-related or not, are included in this endpoint.
Cardiovascular death, heart transplantation, or readmission due to heart failure
Time to the first occurrence of any of the following events: cardiovascular death, heart transplantation, or rehospitalization for heart failure (defined as the primary endpoint).
Cardiovascular death, heart transplantation
Time to the first occurrence of any of the following events: cardiovascular death or heart transplantation (defined as the primary endpoint).
Rehospitalization due to heart failure
Time to first rehospitalization due to heart failure (defined as the primary endpoint).
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Tongji Hospital
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Nanjing Medical University
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Huaxi Hospital
Collaborator
Zhongnan Hospital
Collaborator
Xiangya Hospital
Collaborator
Beijing Anzhen Hospital
Collaborator
The First Affiliated Hospital of Air Force Medicial University
Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Anhui Provincial Hospital
Collaborator
Southwest Medical University
Collaborator
First Hospital of China Medical University
Collaborator
Wuhan Central Hospital
Collaborator
Tianjin Medical University
Collaborator
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