Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 试验地点
- 1
研究概览
简要总结
This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD. The primary objective is to compare baseline small vessel pressure measured with the HEMI (Multi-spectral optical system for microcirculation hemodynamics) device across groups in order to identify microvascular alterations associated with cardiometabolic and renal disease. Secondary objectives include assessment of microvascular responses after post-ischemic hyperemia, evaluation of SPG-derived (Speckle plethysmography) small vessel flow and volume parameters, comparison with reference vascular measurements (including SphygmoCor and ultra-high frequency ultrasound), and evaluation of feasibility, acceptability, and measurement reproducibility. Participation is non-randomized, based on participants' pre-existing clinical condition, and study procedures are non-invasive with an expected visit duration of approximately 60 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Common Inclusion Criteria:
- •Adults aged over 18 years, of both sexes
- •Patients eligible for or affiliated with a social security scheme
- •Patients who have provided written informed consent to participate in the study
排除标准
- •Inability to give informed consent
- •Persons under legal protection (guardianship, trusteeship, or court protection)
- •Language barrier or psychological refusal to read the information
- •Medical conditions with a life expectancy < 1 year according to clinical judgment
- •Ongoing participation restriction due to another clinical research study
- •Pregnant women (due to physiological hemodynamic changes in blood pressure and arterial stiffness during pregnancy)
- •Cardiac arrhythmias: current atrial fibrillation or high-degree atrioventricular block
- •Exclusion Criteria:
- •Hypertension Group
- •Inclusion: Prior diagnosis of arterial hypertension
- •Stable cardiovascular treatment in the previous 1 month
- •Exclusion:
- •CKD with GFR <60 mL/min
- •ACR > 30 mg/mmol
- •Type 2 diabetes Type 2 Diabetes Group
- •Inclusion:
- •Prior diagnosis of type 2 diabetes
- •Stable cardiovascular treatment in the previous 1 month
- •Exclusion:
- •CKD with GFR < 60 mL/min
- •ACR > 30 mg/mmol Moderate CKD Group
- •Inclusion:
- •Moderate CKD (eGFR between 30 and 60 mL/min) (CKD-EPI)
- •Patients scheduled for arterial stiffness assessment as part of routine care
- •Stable cardiovascular treatment in the previous 1 month
- •Exclusion:
- •No specific exclusion criteria beyond common exclusions Severe CKD Group
- •Inclusion:
- •Severe CKD (GFR < 30 mL/min for ≥ 2 months)
- •Patients scheduled for arterial stiffness assessment as part of routine care
- •Stable cardiovascular treatment the previous 1 month
- •Exclusion: No specific exclusion criteria beyond common exclusions20 / 48 C25-07_Protocole_ V1.0_01.12.2025 Healthy Volunteers Group
- •Inclusion: No documented chronic disease
- •Exclusion:
- •Moderate or severe CKD (GFR < 60 mL/min) (CKD-EPI)
- •Hypertension
- •Type 2 diabetes
- •Stable cardiovascular treatment in the previous 1 month
研究组 & 干预措施
Healthy Volunteers
Adults without known hypertension, type 2 diabetes, or chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
干预措施: HEMI device (Device)
Healthy Volunteers
Adults without known hypertension, type 2 diabetes, or chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
干预措施: SPG-NINOX device (Device)
Hypertension Without Chronic Kidney Disease
Adults with hypertension and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
干预措施: HEMI device (Device)
Hypertension Without Chronic Kidney Disease
Adults with hypertension and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
干预措施: SPG-NINOX device (Device)
Type 2 Diabetes Mellitus Without Chronic Kidney Disease
Adults with type 2 diabetes mellitus and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
干预措施: HEMI device (Device)
Type 2 Diabetes Mellitus Without Chronic Kidney Disease
Adults with type 2 diabetes mellitus and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
干预措施: SPG-NINOX device (Device)
Moderate Chronic Kidney Disease
Adults with moderate chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
干预措施: HEMI device (Device)
Moderate Chronic Kidney Disease
Adults with moderate chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
干预措施: SPG-NINOX device (Device)
Severe Chronic Kidney Disease
Adults with severe chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
干预措施: HEMI device (Device)
Severe Chronic Kidney Disease
Adults with severe chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
干预措施: SPG-NINOX device (Device)