HypertensionVITAL-RDNNCT07462572
Virtual Twins as Tools for Personalized Clinical Care in Renal Denervation - Pilot Study
An observational study of Hypertension, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Data collection in order to train the digital twin
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2026to Oct 2028
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in this study are recruited from the active patient population regularly seen in outpatient consultations or during hospitalization at the Hypertension Unit or the Pharmacology Unit of the Georges Pompidou European Hospital (Paris - France)
Who may be able to join
None listed.
Who cannot join
- Pregnancy.
- Presence of skin irritation or non-intact skin at sensor attachment sites (sternum, chest, finger) preventing the possibility to pose sensors.
- Known allergies to ultrasound gel, adhesives, Ag/AgCl electrodes, metals, or plastics.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Hypertension Unit - Georges Pompidou European Hospital
Paris
Laurence AMAR, +33156093771, laurence.amar@aphp.fr
Pharmacology Unit - Georges Pompidou European Hospital
Paris
Rosa Maria BRUNO, +33153987967, rosamaria.bruno@aphp.fr
About this study
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.
Read more
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.
- Conditions
- Hypertension
- Being tested
- Data collection in order to train the digital twin
- Keywords
- Hypertension, Resistant HTN, RDN, Aldosteronism, adrenalectomy.
- Medical subject headings
- Hypertension, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection in order to train the digital twinOther
In this research, results from routine examinations performed to monitor the patient's health will be used to train the digital twin. These include resting blood pressure and heart rate measurements, vascular assessments (pulse wave velocity, carotid stiffness), electrocardiogram (ECG), echocardiography, extracellular water measurement by bioimpedance, cardiopulmonary exercise testing, and routine blood tests for renal and neurohumoral markers.
In addition, the patient's autonomic nervous system will be evaluated using functional tests. The patient will place his or her hand in cold water and squeeze a handgrip device to assess blood pressure and heart rate reactivity (about 20 minutes). The patient will wear a portable device (Calamari) recording heart rhythm, chest vibrations, and blood volume. The patient will also complete questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Patients considered eligible for RDN because of resistant HTN or other clinical indications | Not described Receives: Other: Data collection in order to train the digital twin | |
| Patients with untreated primary hypertension | Not described Receives: Other: Data collection in order to train the digital twin | |
| Patients diagnosed with primary aldosteronism and scheduled for surgical adrenalectomy | Not described Receives: Other: Data collection in order to train the digital twin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the virtual twin in classifying the participants in responders and non-responders to RDN (in the group of patients eligible for RDN because of resistant HTN or other clinical indication)
Responders defined as patients with a reduction of at least 5 mmHg in daytime systolic BP at 3 months post-RDN.
Measured: 3 months post-RDN
Secondary outcomes (2)
Accuracy of the virtual twin in classifying the participants in responders and non-responders to adrenalectomy (in the group of patients with primary aldosteronism)
Responders to treatment are defined as patients with a reduction of at least 5 mmHg in daytime systolic BP at 3 months.
Measured: 3 months post adrenalectomy
Accuracy of the virtual twin in classifying the participants in responders and non-responders after starting antihypertensive treatment (in the group of individuals with untreated primary hypertension)
Responders to treatment are defined as patients with a reduction of at least 5 mmHg in daytime systolic BP at 3 months after antihypertensive treatment start
Measured: 3 months after antihypertensive treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, University of Auckland, New Zealand, University of Pisa, Ecole Polytechnique Fédérale de Lausanne, Delft University of Technology, Maastricht University, AIT Austrian Institute of Technology GmbH, Stichting IMEC-NL, ELEM Biotech, Spain, Westerhof Cardiovascular Research, Netherlands
- Responsible party
- Sponsor
- Investigators
- Rosa Maria BRUNO, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462572
- Sponsor's protocol ID
- APHP251305
- Other IDs
- 2025-A02379-40
- Acronym
- VITAL-RDN
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Twins as Tools for Personalized Clinical Care in Renal Denervation - Pilot Study
- ClinicalTrials.gov ID
- NCT07462572
- Acronym / sponsor ID
- VITAL-RDN / APHP251305
- Conditions
- Hypertension
- Keywords
- Hypertension, Resistant HTN, RDN, Aldosteronism, adrenalectomy.
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- University Ghent, University of Auckland, New Zealand, University of Pisa, Ecole Polytechnique Fédérale de Lausanne, Delft University of Technology, Maastricht University, AIT Austrian Institute of Technology GmbH, Stichting IMEC-NL, ELEM Biotech, Spain, Westerhof Cardiovascular Research, Netherlands
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 10 Mar 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients considered eligible for RDN because of resistant HTN or other clinical indications | – | Other: Data collection in order to train the digital twin |
| Patients with untreated primary hypertension | – | Other: Data collection in order to train the digital twin |
| Patients diagnosed with primary aldosteronism and scheduled for surgical adrenalectomy | – | Other: Data collection in order to train the digital twin |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in this study are recruited from the active patient population regularly seen in outpatient consultations or during hospitalization at the Hypertension Unit or the Pharmacology Unit of the Georges Pompidou European Hospital (Paris - France)
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Pregnancy.
- Presence of skin irritation or non-intact skin at sensor attachment sites (sternum, chest, finger) preventing the possibility to pose sensors.
- Known allergies to ultrasound gel, adhesives, Ag/AgCl electrodes, metals, or plastics.
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 |
|---|---|---|
| Data collection in order to train the digital twinIn this research, results from routine examinations performed to monitor the patient's health will be used to train the digital twin. These include resting blood pressure and heart rate measurements, vascular assessments (pulse wave velocity, carotid stiffness), electrocardiogram (ECG), echocardiography, extracellular water measurement by bioimpedance, cardiopulmonary exercise testing, and routine blood tests for renal and neurohumoral markers. In addition, the patient's autonomic nervous system will be evaluated using functional tests. The patient will place his or her hand in cold water and squeeze a handgrip device to assess blood pressure and heart rate reactivity (about 20 minutes). The patient will wear a portable device (Calamari) recording heart rhythm, chest vibrations, and blood volume. The patient will also complete questionnaires. | Other | Patients considered eligible for RDN because of resistant HTN or other clinical indications, Patients diagnosed with primary aldosteronism and scheduled for surgical adrenalectomy, Patients with untreated primary hypertension |
Primary outcome
Accuracy of the virtual twin in classifying the participants in responders and non-responders to RDN (in the group of patients eligible for RDN because of resistant HTN or other clinical indication)
Time frame: 3 months post-RDN
Responders defined as patients with a reduction of at least 5 mmHg in daytime systolic BP at 3 months post-RDN.
2 secondary outcomes
Accuracy of the virtual twin in classifying the participants in responders and non-responders to adrenalectomy (in the group of patients with primary aldosteronism)
Time frame: 3 months post adrenalectomy
Accuracy of the virtual twin in classifying the participants in responders and non-responders after starting antihypertensive treatment (in the group of individuals with untreated primary hypertension)
Time frame: 3 months after antihypertensive treatment start
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 10 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Rosa Maria BRUNO principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 0 inclusion and 3 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: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Youcef SEKOUR (+33156095823, youcef.sekour@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the virtual twin in classifying the participants in responders and non-responders to RDN (in the group of patients eligible for RDN because of resistant HTN or other clinical indication) (time frame: 3 months post-RDN). 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 10 Mar 2026.