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

N/ANot Yet RecruitingNCT07604922

Institut National de la Santé Et de la Recherche Médicale, France165 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

165

Conditions

Chronic Kidney Disease Hypertension (HTN)

Interventions

HEMI deviceDEVICE

Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel pressure at baseline. Measurements are performed during a single study visit under standardized conditions. In predefined subgroups, additional measurements may be performed after post-ischemic hyperemia and for reproducibility assessment.

SPG-NINOX deviceDEVICE

Non-invasive investigational device used to assess microcirculation through physiological signal acquisition and derivation of microvascular parameters, including small vessel flow and volume-related measures. Measurements are performed during a single study visit under standardized conditions.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

HEMI-derived small vessel pressure at baseline

Small vessel pressure derived from the HEMI non-invasive investigational device under standardized resting conditions at baseline. The primary analysis compares values across the five study groups.

Time frame: Baseline (single study visit, approximately 60 minutes)