Investigating microcirculation with non-invasive devices in adults with or at risk for CKD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center study in France will enroll 165 adults across five groups, including healthy volunteers and patients with hypertension, type 2 diabetes, and varying CKD stages. Researchers will compare baseline microvascular pressure measured by the HEMI device across groups to identify disease-related microvascular changes. They will also assess microvascular responses after post-ischemic hyperemia and evaluate SPG-derived flow and volume parameters, comparing them with reference vascular measurements such as SphygmoCor. The study uses two investigational non-invasive devices to characterize microcirculation in relation to cardiometabolic and renal conditions. Participation requires informed consent and adherence to eligibility criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• INSERM U970, Equipe 7, 56 rue Leblanc
  Paris, France Recruiting

Study contacts

• Study coordinator: Rosa Maria BRUNO, Professor
• Email: rosa-maria.bruno@inserm.fr
• Phone: +33 1 53 98 79 67

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.