Virtual Twins as Tools for Personalized Clinical Care in Renal Denervation - Pilot Study

NCT07462572 | Not Yet Recruiting

• 2 other identifiers: APHP2513052025-A02379-40
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Hypertension

Keywords

Hypertension; Resistant HTN; RDN; Aldosteronism; adrenalectomy.

Outcome Measures

Primary Outcomes (1)

• 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 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)

  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)

  3 months after antihypertensive treatment start

Study Arms (3)

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

Interventions

Data collection in order to train the digital twin OTHER

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 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• University Ghent: collaborator
• University of Auckland, New Zealand: collaborator
• University of Pisa: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• Delft University of Technology: collaborator
• Maastricht University: collaborator
• AIT Austrian Institute of Technology GmbH: collaborator
• Stichting IMEC-NL: collaborator
• ELEM Biotech, Spain: collaborator
• Westerhof Cardiovascular Research, Netherlands: collaborator

Study Sites (2)

Hypertension Unit - Georges Pompidou European Hospital

Paris, France

Location

Pharmacology Unit - Georges Pompidou European Hospital

Paris, France

Location

MeSH Terms

Conditions

Hypertension; Hyperaldosteronism

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rosa Maria BRUNO

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youcef SEKOUR

CONTACT

+33156095823; youcef.sekour@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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).

Locations

FR (2)