NCT07462572Not yet recruiting
Virtual Twins as Tools for Personalized Clinical Care in Renal Denervation - Pilot Study
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
High blood pressure (hypertension) is a common condition. Despite the availability of several medications, many patients continue to have poorly controlled blood pressure. Renal denervation (RDN), a minimally invasive procedure that reduces overactive kidney nerves, has emerged as a potential treatment for certain patients with difficult-to-control hypertension. However, not all patients benefit from this procedure, and there is currently no reliable way to predict who will respond. The VITAL-RDN study (Virtual twins as tools for personalized clinical care in renal denervation - Pilot study) aims to test whether a "digital twin" can help predict which patients are most likely to respond to renal denervation. A digital twin is a personalized computer model built from an individual patient's clinical, biological, and physiological data. It is designed to simulate how that patient's cardiovascular system functions and how it may respond to treatment. The main objective of this pilot study is to evaluate whether the digital twin can accurately distinguish between patients who will respond to renal denervation and those who will not. A responder is defined as a patient whose daytime systolic blood pressure decreases by at least 5 mmHg three months after the RDN. Three groups of patients will be enrolled: 30 patients with resistant hypertension or other clinical indications for renal denervation. 20 patients with untreated primary hypertension who are starting blood pressure-lowering medication. 10 patients with primary aldosteronism who are scheduled for surgical adrenalectomy. In addition to evaluating prediction of response to renal denervation, the study will also assess the performance of the digital twin in predicting response to antihypertensive medication or adrenalectomy in the respective subgroups. If successful, this approach could support more personalized treatment decisions, reduce unnecessary procedures, and improve blood pressure control by matching the right therapy to the right patient.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 5 Mar 2026
- Start date
- Apr 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- High blood pressure
- NCT number
- NCT07462572
What you commit to
- Study type: Observational
- Planned participants: 60
- From Apr 2026 to the primary completion date, Oct 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergies to ultrasound gel, adhesives, Ag/AgCl electrodes, metals, or plastics.
Other
- Pregnancy.
- Presence of skin irritation or non-intact skin at sensor attachment sites (sternum, chest, finger) preventing the possibility to pose sensors.
Criteria the registry did not label
- General inclusion criteria:
- Age between 18 and 90 years for both sexes.
- Patient information and verbal non-opposition expressed by the patient, recorded in writing on the non-opposition form by the investigator.
- Patients affiliated with social security or an equivalent scheme.
- Specific inclusion criteria:
- Patients with clinical indication for RDN:
- Stable treatment for at least 1 month.
- Clinical indication for RDN according to current recommendations or clinical judgment, as part of routine care.
- Patients with untreated primary hypertension:
- Treatment-naïve hypertensive patients or continuous antihypertensive treatment for \< 6 months.
- Office BP \>140/90 mmHg in repeated measures or office BP \>140/90 mmHg in a single visit and home BP or daytime 24h-ABPM BP \>135/85 mmHg.
- Clinical indication to start antihypertensive treatment.
- Patients with clinical indication to surgical adrenalectomy:
- Confirmed diagnosis of primary aldosteronism according to current guidelines.
- Clinical indication for monoliteral surgical adrenalectomy.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pharmacology Unit - Georges Pompidou European Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hypertension Unit - Georges Pompidou European Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.