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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• HEMI-derived small vessel pressure at baseline [Срок оценки: Baseline (single study visit, approximately 60 minutes)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• INSERM U970, Equipe 7, 56 rue Leblanc — Paris

Идентификаторы

NCT: NCT07604922 · C25-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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