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临床试验/NCT07430982
NCT07430982已完成不适用

Evaluation of Endothelial Dysfunction in Geriatric Non-dialysis Chronic Kidney Disease Patients

Muğla Sıtkı Koçman University1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2023年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
试验地点
1
主要终点
Correlation of serum sVE cadherin level and other measurements

研究概览

简要总结

Brief summary template

The goal of this clinical trial is to assess endothelial dysfunction in geriatric non-dialysis CKD patients. The main questions it aims to answer are:

• In geriatric non-dialysis CKD patients, the study aimed to demonstrate the relationship between soluble vascular endothelial cadherin and fibroblast growth factor-23 levels, which are indicators of endothelial dysfunction-and therefore a possible cardiovascular risk factor-using measurement methods such as ultrasonographic carotid intima-media thickness, flow-mediated dilation, and nailfold capillaroscopy.

Participants will have measurement of;

  • ultrasonographic carotid intima-media thickness,
  • flow-mediated dilation,
  • nailfold capillaroscopy
  • venous blood sampling
  • Visit the clinic once,

详细描述

In this single-center study, we aimed to evaluate endothelial dysfunction, the leading cause of mortality in geriatric CKD patients. We kept patient exclusion criteria strict and considered it more rational to conduct this study in a patient group requiring proactive intervention by excluding patients with 'known' cardiovascular disease. For this purpose, we used some non-invasive parameters known in the literature (ultrasonographic measurement of carotid intima-media thickness, nailfold capillaroscopy, flow-mediated dilation). We also planned to measure serum sVE Cadherin levels, which have not been clearly evaluated in geriatric CKD patients before, as well as serum FGF23 levels. We also planned to evaluate the relationship and correlation of these different parameters with other standard biochemical and anthropometric measurements. Patient recruitment for the study took place between May 12, 2023, and September 11, 2023. We followed up for mortality for approximately 2.3 years.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with CKD who are not receiving RRT and those aged 65 and over

排除标准

  • Patients under 65 years of age
  • history of coronary artery disease
  • history of peripheral artery disease
  • atrial fibrillation
  • heart failure
  • active immunosuppressive use
  • active infection
  • history of active malignancy
  • history of cerebrovascular event (ischemic/hemorrhagic)
  • Raynaud's phenomenon
  • renal transplant patients

研究组 & 干预措施

STUDY GROUP

Other

THE ONLY GROUP IN THE STUDY.MEASUREMENT OF CIMT,FMD,NC.

干预措施: Ultrasonographic and Capillary Measurements (Diagnostic Test)

结局指标

主要结局

Correlation of serum sVE cadherin level and other measurements

时间窗: Approximately 122 days were sufficient for patient recruitment for the study. After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.

To investigate the relationship between sVE cadherin levels and ultrasonographic carotid intima-media thickness (CIMT), flow-mediated dilation(FMD), nailfold capillaroscopy(NC) test results measured in patients.

Distribution of sVE cadherin levels in the patient group

时间窗: Approximately 122 days were sufficient for patient recruitment for the study. After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.

sVE cadherin levels

次要结局

  • All-cause mortality(After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.)

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alper Alp

Associate professor, MD

Muğla Sıtkı Koçman University

研究点 (1)

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