Study design and treatment
intolerable adverse, hypotension
RECRUITMENT, TYPE 1 DIABETES MELLITUS, SECONDARY, BLIND, HEART
Participants who met any of the following criteria were excluded from the study: recent use of or intolerable side effects related to an SGLT2 inhibitor, presence of type 1 diabetes mellitus, hypotension symptoms or a systolic blood pressure below 90 mm Hg, and an estimated glomerular filtration rate (eGFR) lower than 30 ml per minute per 1.73 mPatients must have been on stable treatment for at least 3 months prior to recruitment. Then patients were randomized (1:1) to receive dapagliflozin 10 mg once daily, or placebo double blind for 1year; Randomization was undertaken using a computerized permuted-block randomization system (block size of 4) with concealed study group assignments. Throughout the trial, patients maintained their antidiabetes background therapy at a consistent dosage and regimen. Additionally, patients were mandated to undergo standard medication treatment, encompassing an angiotensin-converting-enzyme inhibitor, an angiotensin-receptor blocker, or sacubitril/valsartan in conjunction with a beta-blocker, unless contraindicated or associated with intolerable adverse effects. Furthermore, the utilization of a mineralocorticoid receptor antagonist was recommended. A noteworthy response to dapagliflozin was defined as an (absolute) improvement in LVEF of equal to or greater than 5%.The primary outcome was the change in LVEF value, and the secondary outcomes were the changes in LVED volume, LVES volume, LVED diameter, and LVES diameter.The research protocol obtained approval from the ethics committee at Jiangxi Provincial People’s Hospital. The study adhered to the ethical principles specified in the Declaration of Helsinki. Prior to enrollment in the study, participants provided written consent after receiving comprehensive information about the study.Before initiating dapagliflozin, patients underwent a clinical examination, 12-lead electrocardiography (ECG), transthoracic echocardiography (TTE), and Doppler assessment. The same measurements were repeated after 1 year. The functional evaluation was carried out based on the New York Heart Association (NYHA) classification. TTE was conducted by an observer who was unaware of the patient’s condition. Standard TTE was systematically performed using a commercially available system (Vivid E9, GE Healthcare, France) within 24–72 h prior to dapagliflozin commencement and repeated 1 year after the initiation of dapagliflozin treatment. We have taken similar left echo evaluation in the research conducted by Bayard et al. [