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

NCT07604922 | Not Yet Recruiting DMC

• 1 other identifier: C25-07
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Kidney Disease; Hypertension (HTN); Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• HEMI-derived small vessel pressure at baseline

  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)

Study Arms (5)

Healthy Volunteers

EXPERIMENTAL

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; Device: SPG-NINOX device

Hypertension Without Chronic Kidney Disease

EXPERIMENTAL

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; Device: SPG-NINOX device

Type 2 Diabetes Mellitus Without Chronic Kidney Disease

EXPERIMENTAL

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; Device: SPG-NINOX device

Moderate Chronic Kidney Disease

EXPERIMENTAL

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; Device: SPG-NINOX device

Severe Chronic Kidney Disease

EXPERIMENTAL

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; Device: SPG-NINOX device

Interventions

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.

Healthy Volunteers; Hypertension Without Chronic Kidney Disease; Moderate Chronic Kidney Disease; Severe Chronic Kidney Disease; Type 2 Diabetes Mellitus Without Chronic Kidney Disease

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.

Healthy Volunteers; Hypertension Without Chronic Kidney Disease; Moderate Chronic Kidney Disease; Severe Chronic Kidney Disease; Type 2 Diabetes Mellitus Without Chronic Kidney Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Hypertension Group
• Stable cardiovascular treatment in the previous 1 month
• CKD with GFR \<60 mL/min
• ACR \> 30 mg/mmol
• Type 2 diabetes Type 2 Diabetes Group
• Prior diagnosis of type 2 diabetes
• Stable cardiovascular treatment in the previous 1 month
• CKD with GFR \< 60 mL/min

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• University of Turku: collaborator
• Imec: collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Rosa Maria BRUNO, Professor

CONTACT

+33 1 53 98 79 67; rosa-maria.bruno@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants are assigned in a non-randomized manner to one of five parallel groups according to their pre-existing clinical condition (healthy volunteers, hypertension without CKD, type 2 diabetes without CKD, moderate CKD, severe CKD). All groups undergo the same non-invasive study assessments with the investigational devices (HEMI and SPG-NINOX) during a single study visit, with comparisons performed across groups. Additional predefined subgroups may undergo supplementary assessments (e.g., post-ischemic hyperemia or reproducibility testing).

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): September 15, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share