Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease

Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease

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.

Inclusion Criteria:

• 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

Common Exclusion Criteria:

• 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