NCT05359263招募中2 期
A 6-Month, Randomized, Double-Blind Study to Evaluate the Effect of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease
Tor Biering-Sørensen1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2022年6月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Change in LV mass index assessed by echocardiography at 6 months
研究概览
简要总结
The purpose of this study is to investigate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease.
详细描述
The study is a 6-month, investigator-initiated, randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease. The study population will consist of approximately 222 adults with chronic kidney disease - defined as a glomerular filtration rate (GFR) of 20-60 mL/min/1.73m2, in treatment with maximally tolerated ACEi or ARB. Patients will be randomized to either 10 mg dapagliflozin or placebo. Patients will be assessed by measurement of echocardiography, pulse wave velocity, blood samples, urine samples, quality of life, depressive symptoms, and cognitive function at baseline and after 6 months of treatment.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Signed informed consent
- •≥ 18 years of age
- •Chronic kidney disease (CKD), defined as evidence of decreased eGFR (eGFR ≥20 and <60 mL/minute per 1.73 m2) or between eGFR ≥60 and <90 mL/minute per 1.73 m2 with urinary albumin:creatinine ratio ≥200 mg/g or protein:creatinine ratio ≥300 mg/g
- •Stable treatment with clinically appropriate doses of ACEi/ARB among CKD patients with proteinuria and uptitrated to maximal recommended or tolerated dose for at least 4 weeks before randomization, if not medically contraindicated
- •For patients with type 2 diabetes:
- •Stable antihyperglycemic treatment > 30 days before screening
- •Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device
- •Ability to understand and read Danish
排除标准
- •Type 1 diabetes
- •For patients with type 2 diabetes:
- •History of diabetic ketoacidosis
- •Patients undergoing dialysis
- •History of organ transplant
- •Treatment with SGLT2 inhibitor within 8 weeks prior to enrolment
- •Known allergy or hypersensitivity to SGLT2 inhibitors or Placebo ingredients
- •Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks of enrolment
- •Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment
- •Any condition outside the renal and cardiovascular study area with a life expectancy of <2 years based on investigator's clinical judgement
- •Hepatic impairment (aspartate transaminase or alanine transaminase >3 times the upper limit of normal [ULN] or total bilirubin >2 times the ULN at the time of enrolment)
- •Known blood-borne diseases, such as Hepatitis A, B, C, D, and E, and Human immunodeficiency virus (HIV) types 1 and 2, Ebola, Lassa fever virus.
- •Female patients who are pregnant, lactating, or are considering becoming pregnant during the study or for 6 months after study completion
- •Participation in another clinical study with an investigational product within the last month prior to enrolment
- •Inability to understand or comply with the investigational product, procedures, and/or follow-up or any conditions that may prevent the participant to complete the study
研究组 & 干预措施
Dapagliflozin 10 mg once daily
Experimental
干预措施: Dapagliflozin 10 mg (Drug)
Placebo once daily
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in LV mass index assessed by echocardiography at 6 months
时间窗: 6 months
次要结局
- Change in hemoglobin at 6 months(6 months)
- Change in LV end-diastolic volume at 6 months(6 months)
- Change in N-terminal pro B-type natriuretic peptide (NT-pro-BNP) at 6 months(6 months)
- Change in estimated glomerular filtration rate (eGFR) 6 months(6 months)
- Change in urinary albumin-to-creatinine ratio (UACR) at 6 months(6 months)
- Change in LVEF assessed by echocardiography at 6 months(6 months)
- Change in GLS assessed by echocardiography at 6 months(6 months)
- Change in LV mass assessed by echocardiography at 6 months(6 months)
- Change in LV end-systolic volume at 6 months(6 months)
- Change in LA volume index assessed by echocardiography at 6 months(6 months)
- Change in high sensitivity troponin I (hs-TNI) at 6 months(6 months)
研究者
Tor Biering-Sørensen
Research Director, MD, PhD, MPH
Herlev and Gentofte Hospital
研究点 (1)
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