KCT0008535招募中Unknown
Effect of SGLT2 inhibitor to epicardial adipose tissue thickness in patient with heart failure with left ventricular ejection fraction over 40% and increased epicardial adipose tissue thickness
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •= 18 years and <85 years at screening
- •-Male or female patients
- •-Diagnosis of HF with EF = 40% which includes:
- •?Symptoms ± signs (as defined in 2016 European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure)
- •?Ejection fraction = 40% (by Simpson)
- •?Increased LV filling pressures at rest or during exercise determined by echocardiography (LV diastolic dysfunction grade II/III and/or positive diastolic stress test) [according to American Society of Echocardiography and European Association of Cardiovascular Imaging (ASE/EACVI) Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography, 2016]
- •-Elevated NT-proBNP > 225 pg/ml for patients without AF, OR > 375 pg/ml for patients with AF
- •-Both ambulatory and hospitalized patients
- •-Epicardial adipose tissue (EAT) thickness > 5 mm measured at end-diastole
- •-Signed and dated informed consent
排除标准
- •-Patients being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) within the 8 weeks prior to the screening visit.
- •-Impaired renal function, defined as eGFR <20 ml/min/1.73 m² of body-surface-area (CKD-EPI)
- •-Systolic blood pressure > 180 mmHg or < 90 mmHg
- •-Other conditions that may be responsible for impaired diastolic function such as hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, complex congenital heart disease and etc.
- •-Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy, or transcatheter aortic valve replacement) or CRT within the 90 days after the screening visit.
- •-History of diabetic ketoacidosis
- •-Participation in any interventional clinical trial (with an investigational drug or device) that is not an observational registry within 15 days of the screening visit.
- •-History of hypersensitivity to SGLT2 inhibitors
- •-Indications of liver disease
- •-Type 1 Diabetes Mellitus (T1DM)
- •-Acute genital infection or urinary tract infection
- •-Current history of bladder cancer
- •-For women of child-bearing potential: Current or planned pregnancy or currently lactating
- •-Life expectancy <6 months at the screening visit
- •-Any other condition that in the judgment of the investigator would jeopardize the patient's participation in the study or that may interfere with the interpretation of study data or if the patient is considered unlikely to comply with study procedures, restrictions and requirements
研究者
相似试验
已完成
不适用
Effect of high dose SGLT-2 inhibitor on fatty livertype2 diabetes/fatty liverJPRN-UMIN000047270Konuma Internal medicine Gastroenterology Clinic directer20
已完成
1 期
SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity PilotPre-diabetesObesityNCT04907214Vanderbilt University Medical Center29
招募中
不适用
The Effect of SGLT-2 Inhibitors on Epicardial Adipose Tissue and Cardiac Function in T2DM Patients With CAD (EpiCAD)Coronary Artery DiseaseNCT06128096Clinical Research Centre, Malaysia360
尚未招募
不适用
The impact of the SGLT2 inhibitor on cardiovascular risk factors in patients with type 2 diabetes, an explanatory randomized trialType 2 diabetesJPRN-UMIN000021669Tokyo Medical University60
招募中
Unknown
To study the effect of a medication(SGLT 2 inhibitor) on the structural changes in the heart in patients with poor heart pumping and irregular heart rhythmCTRI/2023/08/056196Kasturba Medical College