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NCT07604922Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 31 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
165 (estimated)
First submitted
18 May 2026
Start date
15 Sept 2026
Primary completion date
15 Mar 2028
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
NCT number
NCT07604922

What you commit to

  • Study type: Interventional
  • Planned participants: 165
  • From 15 Sept 2026 to the primary completion date, 15 Mar 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
INSERM U970, Equipe 7, 56 rue Leblanc
Coordinator of this site? Confirm its status		ParisFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.