Virtual Twins as Tools for Personalized Clinical Care in Renal Denervation - Pilot Study (VITAL-RDN)

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 Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Data collection in order to train the digital twin

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Youcef SEKOUR; Phone Number: +33156095823; Email: youcef.sekour@aphp.fr

Study Locations

• France
  • Paris, France
    • Hypertension Unit - Georges Pompidou European Hospital
    • Contact: Laurence AMAR; Phone Number: +33156093771; Email: laurence.amar@aphp.fr
  • Paris, France
    • Pharmacology Unit - Georges Pompidou European Hospital
    • Contact: Rosa Maria BRUNO; Phone Number: +33153987967; Email: rosamaria.bruno@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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)

Description

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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients considered eligible for RDN because of resistant HTN or other clinical indications	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.
Patients with untreated primary hypertension	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.
Patients diagnosed with primary aldosteronism and scheduled for surgical adrenalectomy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months post-RDN

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	3 months after antihypertensive treatment start

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: University of Pisa; University Ghent; Maastricht University; Ecole Polytechnique Fédérale de Lausanne; University of Auckland, New Zealand; Delft University of Technology; AIT Austrian Institute of Technology GmbH; Stichting IMEC-NL; ELEM Biotech, Spain; Westerhof Cardiovascular Research, Netherlands
• Investigators: Principal Investigator: Rosa Maria BRUNO, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; RDN; Resistant HTN; Aldosteronism; adrenalectomy.
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hypertension; Hyperaldosteronism; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: APHP251305; 2025-A02379-40 (Other Identifier: ANSM (French National Agency for the Safety of Medicines and Health Products))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
• IPD Sharing Time Frame: Two years after the last publication

IPD Sharing 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).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No