Virtual Twins as Tools for Personalized Clinical Care in Renal Denervation - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with untreated primary hypertension
干预措施: Data collection in order to train the digital twin (Other)
Patients considered eligible for RDN because of resistant HTN or other clinical indications
干预措施: Data collection in order to train the digital twin (Other)
Patients diagnosed with primary aldosteronism and scheduled for surgical adrenalectomy
干预措施: Data collection in order to train the digital twin (Other)
结局指标
主要结局
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)
时间窗: 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.
次要结局
- 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)