Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Starting soon · Not applicable
Conditions studied: Chronic Kidney Disease, Hypertension (HTN), Type 2 Diabetes Mellitus (T2DM)
In brief
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.
Key facts
- Study ID
- NCT07604922
- Run by
- Institut National de la Santé Et de la Recherche Médicale, France
- People needed
- 165
- Starts
- 2026-09-15
- Expected to finish
- 2028-09-15
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- INSERM U970, Equipe 7, 56 rue Leblanc — Paris, France
Full record on ClinicalTrials.gov
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