Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HEMI device, SPG-NINOX device.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease, Hypertension (HTN), Type 2 Diabetes Mellitus (T2DM). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Device HEMI device
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. - Device SPG-NINOX device
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.
Primary outcome measures
- HEMI-derived small vessel pressure at baseline [Time frame: Baseline (single study visit, approximately 60 minutes)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- INSERM U970, Equipe 7, 56 rue Leblanc — Paris
Identifiers
NCT: NCT07604922 · C25-07