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

N/ANot Yet RecruitingNCT07462572

Assistance Publique - Hôpitaux de Paris60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hypertension

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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)

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