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NCT Number: NCT07604922

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

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.

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Key information

Conditions

Chronic Kidney Disease Cardiovascular Diseases Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Hypertension (HTN) Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Type 2 Diabetes Mellitus (T2DM) Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INSERM U970, Equipe 7, 56 rue Leblanc

Paris, 75015, France

Location contact

Rosa Maria BRUNO, Pr

CONTACT

[email protected]

+33 1 53 98 79 67

Rosa Maria BRUNO, Pr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemi device

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.

SPG-NINOX device

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rosa Maria BRUNO, Professor

CONTACT

[email protected]

+33 1 53 98 79 67

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Imec
  • University of Turku

Registry information

Acronym: STIMULUS-CKD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 22, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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