Chronic Kidney Disease, Hypertension (HTN), Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
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
DEVICEHEMI 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.
DEVICESPG-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.
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
University of Turku
Imec
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Participants are assigned in a non-randomized manner to one of five parallel groups according to their pre-existing clinical condition (healthy volunteers, hypertension without CKD, type 2 diabetes without CKD, moderate CKD, severe CKD). All groups undergo the same non-invasive study assessments with the investigational devices (HEMI and SPG-NINOX) during a single study visit, with comparisons performed across groups. Additional predefined subgroups may undergo supplementary assessments (e.g., post-ischemic hyperemia or reproducibility testing).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HEMI-derived small vessel pressure at baseline | Baseline (single study visit, approximately 60 minutes) | 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. |
Countries
France
Contacts
CONTACTRosa Maria BRUNO, Professor
Outcome results
None listed