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Completed

NCT Number: NCT07430982

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

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,

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Key information

Conditions

Geriatrics Carotis Intima-media Thickness Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mugla Sitki Kocman University

Muğla, 48000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Ultrasonographic and Capillary Measurements

Diagnostic Test

All measurements will be applied to the entire patient group.

Other names: measurement of flow-mediated dilation, measurement of nailfold capillaroscopy, measurement of ultrasonographic carotid intima-media thickness

Primary outcomes

  1. Correlation of serum sVE cadherin level and other measurements

    Time frame: 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.

  2. Distribution of sVE cadherin levels in the patient group

    Time frame: 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

Secondary outcomes

  1. All-cause mortality

    Time frame: After patient recruitment was completed, we followed the patients for approximately 844 days, monitoring their survival/death status.

    Evaluation of those who died and those who survived after approximately over 2 years.

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Acronym: EDGeriatrCKD

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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