Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chro… (NCT07604922) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
France165 participantsStarted 2026-06-15
Plain-language 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 (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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 treatm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to wait for it or focus on other options in the meantime?
2The trial is measuring something called 'HEMI-derived small vessel pressure' — can you explain what that means for my kidneys or blood vessels, and whether learning that information could actually change how my care is managed?
3Since this appears to be an observational or measurement study rather than a treatment trial, does participating mean I'd receive any new therapy, or would it mainly involve tests and monitoring?
4Given that I have chronic kidney disease, hypertension, or type 2 diabetes — or am at risk for them — how would you assess whether my specific situation makes me a good candidate to discuss with the study team when enrollment opens?
5Are there standard diagnostic tools or monitoring approaches already available for small vessel health that my care team is using, and how does what this trial is investigating compare to what I'm already receiving?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HEMI-derived small vessel pressure at baseline
Timeframe: Baseline (single study visit, approximately 60 minutes)
Trial details
NCT IDNCT07604922
SponsorInstitut National de la Santé Et de la Recherche Médicale, France