Overview

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.

Eligibility

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