NCT07403955尚未招募不适用
A Randomized Controlled Clinical Study on the Effect of Dapagliflozin on Myocardial Strain in Patients With Acute Heart Failure
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 188
- 主要终点
- left ventricular global longitudinal strain (LVGLS)
研究概览
简要总结
The goal of this clinical trial is to assess the impact of dapagliflozin on myocardial strain in patients with acute heart failure using speckle tracking echocardiography (STE).
The main questions it aims to answer are:
- Does dapagliflozin improve left ventricular remodeling as well as cardiac systolic and diastolic function?
- Can STE more accurately assess the impact of dapagliflozin on myocardial strain in patients with acute heart failure? Researchers will compare patients receiving oral dapagliflozin to those not receiving it to see if dapagliflozin works to improve left ventricular remodeling as well as cardiac systolic and diastolic function.
Participants will:
- Take dapagliflozin or not every day for 1 month
- Take dapagliflozin for the next 2 months
- Visit the clinic at Month 1 and Month 3 for checkups and tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent from patient or next of kin； Eighteen years and older; Admitted to hospital due to acute heart failure； eGFR> 25ml /min/1.73m2 (calculated by the MDRD equation)； Eligible patients will be enrolled within 24 hours to 14 days after admission, while still hospitalized and in a stable condition.
排除标准
- •Type I diabetes mellitus; Systolic blood pressure < 90mmHg at enrollment or positive inotropic drugs are required at enrollment or are expected to be used during hospitalization; Non-cardiac dyspnea； Known hypersensitivity to dapagliflozin； Previous treatment with any SGLT2 inhibitor； History of diabetic ketoacidosis within 3 months； Patients on dialysis； Current atrial fibrillation； Poor echocardiographic images quality prohibiting speckle tracking echocardiography analysis； History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3) or asymptomatic sustained ventricular tachycardia，congenital long QT syndrome, history of QT prolongation associated with other medications that required discontinuation of that medication; Diagnosis of hypertrophic obstructive cardiomyopathy, reversible cardiomyopathy (such as stress cardiomyopathy), cardiac infiltrative diseases (such as myocardial amyloidosis), constrictive pericarditis, severe valvular heart disease (moderate or severe aortic stenosis, severe aortic regurgitation, moderate or severe mitral stenosis, severe mitral regurgitation, heart valve disease expected to undergo surgery during the trial period); Various serious diseases that affect the clinical course of the subjects, such as acute exacerbation of chronic obstructive pulmonary disease and severe liver function impairment (Child-Pugh Grade C), severe anemia (hemoglobin < 90g/L), gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of the test drug, acute or chronic pancreatitis, current urinary or reproductive system infections, and a recorded history of active or suspected malignant tumors or a clear history of malignant tumors within one year prior to screening; Diffuse edema with 4+ edema, estimated blood volume exceeding 40 pounds (18kg); Pregnant, or currently breastfeeding or in the preconception period; Failure to follow the research evaluation schedule for follow-up, or deemed unsuitable for participation by the investigator
研究组 & 干预措施
intervention group
Experimental
Standard treatment combined with dapagliflozin tablet 10mg qd for 3 months
干预措施: Dapagliflozin 10mg Tab (Drug)
control group
No Intervention
Dapagliflozin tablet 10mg qd was added for two months after one month of standard treatment
结局指标
主要结局
left ventricular global longitudinal strain (LVGLS)
时间窗: at 3 months
the change in LVGLS from baseline
次要结局
- left ventricular global longitudinal strain (LVGLS)(at 1 month and 3 months)
- peak atrial contraction strain（PACS），peak atrial longitudinal strain（PALS），right ventricular global longitudinal strain（RVGLS）(at 1 month and 3 months)
- all-cause mortality， Cardiovascular death， Heart failure hospitalization(at 1 month and 3 months)
研究者
相似试验
招募中
4 期
Early use of dapagliflozin in patients with acute myocardial infarction and reduced ejection fraction: the randomized ARMYDA-9 Dapagliflozin trialAcute Myocardial Infarction2025-521481-10-00Azienda Ospedaliero-Universitaria Maggiore Della Carita140
已完成
4 期
A Study Between Dapagliflozin and Empagliflozin Effect on NAFLD in Patients With Type 2 Diabetes.NCT07363707Beni-Suef University108
已完成
不适用
Evaluation of the Effect of SGLT-2 Inhibitors on Cardiac Remodeling in Post Myocardial Infarction PatientsMyocardial Remodeling, VentricularMyocardial InfarctionDiabetes Mellitus, Type 2NCT05335629Ain Shams University54
招募中
4 期
RECURrence of Atrial Fibrillation after cardioversion of patients randomized to open-label treatment with dapagliflozin or usual care (RECUR-AF)Atrial fibrillation2024-513719-28-00Karolinska University Hospital1,600
招募中
4 期
Effect of Empagliflozin on InflammationPCINCT07292909Hotel Dieu de France Hospital100