Chronic Kidney DiseaseSTIMULUS-CKDNCT07604922
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
A study testing HEMI device and SPG-NINOX device in people with Chronic Kidney Disease and Hypertension (HTN), run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Hypertension (HTN), Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- HEMI device and SPG-NINOX device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2026to 15 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Stable cardiovascular treatment in the previous 1 month
- Prior diagnosis of type 2 diabetes
- Stable cardiovascular treatment in the previous 1 month
- 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
- 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
Who cannot join
- Hypertension Group
- CKD with GFR <60 mL/min
- ACR > 30 mg/mmol
- Type 2 diabetes Type 2 Diabetes Group
- CKD with GFR < 60 mL/min
- ACR > 30 mg/mmol Moderate CKD Group
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- No specific exclusion criteria beyond common exclusions Severe CKD Group
- Moderate or severe CKD (GFR < 60 mL/min) (CKD-EPI)
- Hypertension
- Type 2 diabetes
- Stable cardiovascular treatment in the previous 1 month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
INSERM U970, Equipe 7, 56 rue Leblanc
Paris, 75015
Rosa Maria BRUNO, Pr, +33 1 53 98 79 67, rosa-maria.bruno@inserm.fr
Rosa Maria BRUNO, Pr
About this study
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.
- Being tested
- HEMI device, SPG-NINOX device
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMI deviceDevice
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 deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: HEMI device; Device: SPG-NINOX device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (single study visit, approximately 60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start17 Sep 2026
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- University of Turku, Imec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604922
- Sponsor's protocol ID
- C25-07
- Acronym
- STIMULUS-CKD
- Status last verified
- Nov 2026
- First submitted
- 18 May 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07604922
- Acronym / sponsor ID
- STIMULUS-CKD / C25-07
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- University of Turku, Imec
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: HEMI device, Device: SPG-NINOX deviceAdults 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. |
| Hypertension Without Chronic Kidney Disease | Experimental | Device: HEMI device, Device: SPG-NINOX deviceAdults 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. |
| Type 2 Diabetes Mellitus Without Chronic Kidney Disease | Experimental | Device: HEMI device, Device: SPG-NINOX deviceAdults 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. |
| Moderate Chronic Kidney Disease | Experimental | Device: HEMI device, Device: SPG-NINOX deviceAdults with moderate chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. |
| Severe Chronic Kidney Disease | Experimental | Device: HEMI device, Device: SPG-NINOX deviceAdults with severe chronic kidney disease, undergoing non-invasive microcirculation assessment with the investigational devices (HEMI and SPG-NINOX) during a single study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Common Inclusion 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
Key exclusion criteria (11 listed)
- Hypertension Group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEMI deviceNon-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 | 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 deviceNon-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. | Device | Healthy Volunteers, Hypertension Without Chronic Kidney Disease, Moderate Chronic Kidney Disease, Severe Chronic Kidney Disease, Type 2 Diabetes Mellitus Without Chronic Kidney Disease |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEMI device and SPG-NINOX device in people with Chronic Kidney Disease and Hypertension (HTN), run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosa Maria BRUNO, Professor (+33 1 53 98 79 67, rosa-maria.bruno@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HEMI-derived small vessel pressure at baseline (time frame: Baseline (single study visit, approximately 60 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.