Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease (STIMULUS-CKD)

Institut National de la Santé Et de la Recherche Médicale, France

Status: Not yet enrolling

Conditions: Chronic Kidney Disease; Type 2 Diabetes Mellitus (T2DM); Hypertension (HTN)

Treatments: Device: HEMI device; Device: SPG-NINOX device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07604922

C25-07

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 5 patient groups

Healthy Volunteers

Experimental group

Description:

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.

Treatment:

Device: SPG-NINOX device

Device: HEMI device

Hypertension Without Chronic Kidney Disease

Experimental group

Description:

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.

Treatment:

Device: SPG-NINOX device

Device: HEMI device

Type 2 Diabetes Mellitus Without Chronic Kidney Disease

Experimental group

Description:

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.

Treatment:

Device: SPG-NINOX device

Device: HEMI device

Moderate Chronic Kidney Disease

Experimental group

Description:

Adults with moderate chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.

Treatment:

Device: SPG-NINOX device

Device: HEMI device

Severe Chronic Kidney Disease

Experimental group

Description:

Adults with severe chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.

Treatment:

Device: SPG-NINOX device

Device: HEMI device