Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease (STIMULUS-CKD)

May 18, 2026 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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 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 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Volunteers
Adults without known hypertension, type 2 diabetes, or chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
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.
Experimental: Hypertension Without Chronic Kidney Disease
Adults with hypertension and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
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.
Experimental: Type 2 Diabetes Mellitus Without Chronic Kidney Disease
Adults with type 2 diabetes mellitus and without chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
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.
Experimental: Moderate Chronic Kidney Disease
Adults with moderate chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
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.
Experimental: Severe Chronic Kidney Disease
Adults with severe chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HEMI-derived small vessel pressure at baseline
Time Frame: 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.
Baseline (single study visit, approximately 60 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

University of Turku
Imec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

March 15, 2028

Study Completion (Estimated)

September 15, 2028

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C25-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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