An observational study in Hypertension, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 60 is below the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
General inclusion criteria:
Specific inclusion criteria:
Patients with clinical indication for RDN:
Patients with untreated primary hypertension:
Patients with clinical indication to surgical adrenalectomy:
Exclusion Criteria:
Other: Data collection in order to train the digital twin
Other: Data collection in order to train the digital twin
Other: Data collection in order to train the digital twin
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.
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.
Time frame: 3 months post-RDN
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.
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)
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
Time frame: 3 months after antihypertensive treatment start
Plan to share: 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
Supporting information: Study protocol, Informed consent form
Time frame: Two years after the last publication
Access criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder and other collaborators could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris →