Not yet recruitingNAINTERVENTIONAL

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

Doctors in France are running a study to understand how small blood vessels in the body are affected by conditions like chronic kidney disease, high blood pressure, and type 2 diabetes. They're using two new, gentle devices called HEMI and SPG-NINOX, which don't involve needles or surgery, to measure blood flow and pressure. The study includes 165 adults split into five groups: healthy volunteers, people with high blood pressure, people with type 2 diabetes, and people with moderate or severe kidney disease. The main aim is to see if these devices can spot early changes in the small blood vessels that are linked to heart, metabolism, and kidney health. They also want to check how easy and reliable the devices are to use.

At a glance

Status

Not yet recruiting

Phase

Sponsor

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

Enrolment target

165

Start

15 Jun 2026

Estimated completion

15 Sep 2028

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

What is this study about?

This study is happening in France and is all about understanding how the tiny blood vessels in your body, called microcirculation, work, especially if you have chronic kidney disease, high blood pressure, or type 2 diabetes, or are at risk of getting them. Think of these tiny vessels as the body's delivery system for oxygen and nutrients to all your cells. When they don't work properly, it can affect your overall health, including your heart and kidneys.

The researchers are testing two new pieces of equipment, devices called HEMI and SPG-NINOX. These devices are "non-invasive," meaning they don't go inside your body – no needles or surgery are involved. They're trying to see if these devices can accurately measure things like the pressure and flow of blood in these small vessels. The study will compare these measurements in different groups of people, including healthy volunteers and those with various health conditions, to see if there are specific patterns or changes linked to kidney disease, high blood pressure, or diabetes.

The main goal is to identify early changes in these small blood vessels that might be connected to heart, metabolic, and kidney problems. By understanding these changes better, doctors hope to find new ways to detect and manage these conditions in the future. The study also aims to figure out how practical and reliable these new devices are to use in a real-world setting.

Key takeaways

Study examines small blood vessels in people with or at risk of kidney disease, high blood pressure, or type 2 diabetes.
Uses two new, gentle devices (HEMI and SPG-NINOX) for measurements.
Participation involves a single, one-hour, non-invasive visit.
Aims to find early signs of disease in blood vessels to help future patient care.
No new medications or treatments are given during the study.
You can withdraw at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or over. You'll need to be covered by a social security scheme (like the NHS in the UK, but for France) and be able to give written permission to take part. You can't join if you're under legal protection (like guardianship), can't understand the information due to a language barrier or other reasons, or if doctors expect you to live for less than a year. Pregnant women cannot participate because pregnancy changes how blood flows.

There are also specific rules for each group. For example, if you have high blood pressure or type 2 diabetes, you can't have advanced kidney disease. If you have moderate or severe kidney disease, you'll need to meet certain criteria about your kidney function. Healthy volunteers should not have these conditions.

Finally, you can't be taking part in another clinical research study at the same time, and you shouldn't have certain heart rhythm problems like atrial fibrillation, as these can affect the test results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you covered by a social security healthcare scheme?
Can you provide written permission to take part?
Are you not pregnant?
Do you not have certain serious heart rhythm problems?
Are you not participating in another research study currently?

Answer every question to see your result.

What does participation involve?

If you take part in this study, your visit is expected to last about 60 minutes. During this time, you'll have measurements taken using the two investigational devices, HEMI and SPG-NINOX. These are non-invasive, meaning they won't involve any needles or surgical procedures. The researchers will also compare these measurements with standard methods currently used to check blood vessels, like those that measure artery stiffness or use special ultrasound. You won't be given any new medication as part of this study, and there's no ongoing follow-up required after your single visit. Your participation group will be decided based on your current health condition.

Potential risks and benefits

Taking part in this study is likely to involve very little risk, as all the procedures are non-invasive and shouldn't cause discomfort. For example, there are no medicines involved, and no needles or surgery. The main benefit to you might be a better understanding of your microcirculation, but the biggest benefit is contributing to medical knowledge that could help future patients. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

INSERM U970, Equipe 7, 56 rue Leblanc
Verified postcode
Paris, France

Common questions

What do 'microcirculation' and 'small blood vessels' mean?

These terms refer to the smallest blood vessels in your body, like capillaries, which are responsible for delivering oxygen and nutrients to all your tissues.

Are the devices HEMI and SPG-NINOX safe?

Yes, both devices are non-invasive, meaning they don't go inside your body and don't involve needles or surgery, so they are considered very safe.

Will I get any medication or treatment in this study?

No, this study is observational, meaning it only involves measurements and no new medications or treatments will be given.

How long will my visit to the clinic take?

The entire visit for the study procedures is expected to take about 60 minutes.

Will my regular doctor be involved?

The study team will assess your eligibility, but it's always a good idea to talk to your own doctor before deciding to join any study.

How to find out more

Rosa Maria BRUNO, Professor

rosa-maria.bruno@inserm.fr +33 1 53 98 79 67 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.