CompletadoNCT06877234Registro de ClinicalTrials.gov

Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN（FIM）

Essential Hypertension

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: 18 años - 65 años
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 10 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This study is a prospective and exploratory clinical study, enrolling patients with essential hypertension. This study is planned to be conducted in 2 research institutions in China, and a total of 6 subjects are planned to be included. After the subjects sign the informed consent form (ICF) approved by the ethics committee, they will enter the screening procedure. Subjects who meet the inclusion criteria and do not meet any of the clinical exclusion criteria will be enrolled after undergoing renal artery CTA angiography.

All patients will undergo clinical evaluation and blood pressure measurement during the operation, at the time of discharge, and at 1 month, 2 months, 3 months, and 6 months after the operation.

It is recommended that the anti-hypertensive medications used before the operation should not be changed within 6 months after the operation for the cases. When the systolic blood pressure (SBP) is ≥ 180 mmHg or there are clinical symptoms caused by hypertension, the drug dosage should be increased as a priority, and then the anti-hypertensive medications should be adjusted. When the systolic blood pressure (SBP) is ≤ 120 mmHg or there are clinical symptoms caused by a decrease in blood pressure, the anti-hypertensive medications should be reduced.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Males or females aged 18 years old or above and 65 years old or below; Patients with essential hypertension; Patients who have been stably taking 2 or more antihypertensive drugs at conventional doses continuously for at least 4 weeks before enrollment, and whose blood pressure meets the following conditions: (1) The systolic blood pressure measured in the outpatient clinic is ≥150 mmHg and ≤180 mmHg, and the diastolic blood pressure measured in the outpatient clinic is ≥90 mmHg; (2) The systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) is between 135 mmHg and 170 mmHg; The course of hypertension is more than 6 months; The diameter of the renal artery evaluated by renal artery CTA is ≥3 mm and the length is ≥20 mm; The patient or his/her legal representative signs a written informed consent form approved by the ethics committee before screening;

Exclusion Criteria:

Complicated with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (defined as plasma Hb1Ac ≥ 10.0%); Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m²; Previous implantation of an implantable cardioverter-defibrillator (ICD) or a pacemaker; History of myocardial infarction, syncope, intracerebral hemorrhage or cerebral infarction within 6 months before signing the informed consent form; Severe valvular heart stenosis; Any factors that may interfere with blood pressure measurement under any circumstances (for example, the patient has severe peripheral vascular disease, abdominal aortic aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia, severe anemia); Patients with sleep apnea syndrome; Females who are pregnant or breastfeeding, or those who have a plan to conceive within the next year; Other serious organic diseases with an expected lifespan of less than 12 months; Participation in other clinical trials before screening and not yet completed;

Preoperative exclusion criteria based on CTA imaging:

a. Visual inspection shows that the diameter stenosis of the renal artery on either side \> 50% or there is a renal artery aneurysm on either side; b. Previous history of renal artery interventional treatment; Other situations that the investigator deems unsuitable for enrollment.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: No aplica
Enmascaramiento: Sin enmascaramiento

Exploratory Clinical Study of the Ultrasound Nerve Ablation System

No informado en este registro.

Procedure: Ultrasonic Nerve Ablation System

Ultrasonic Nerve Ablation System PROCEDURE

Treatment of patients with essential hypertension using the ultrasonic nerve ablation system

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

The change in the average daytime systolic blood pressure two months after the operation

Plazo: Two months after the operation

That is, the difference between the average daytime (from 7:00 to 22:00) systolic blood pressure measured before the operation and the average daytime systolic blood pressure measured during the follow-up visit two months after the operation

Major adverse events within 30 days after the operation

Plazo: Within 30 days after the operation

Major adverse events include: all-cause mortality, renal complications, renal artery embolism events, complications of interventional treatment, hypertensive/hypotensive crises during hospitalization, and major cardiovascular and cerebrovascular complications.

Medidas secundarias

The changes in the average systolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation

Plazo: 1 month, 3 months, 6 months after the operation

Changes in the average systolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation (1 month, 3 months, 6 months) That is, the difference between the average systolic blood pressure of ambulatory blood pressure measured during the daytime (7:00-22:00), at night (22:00-7:00) and over 24 hours before the operation and the average systolic blood pressure of ambulatory blood pressure measured during the daytime, at night and over 24 hours during the postoperative follow-up.

Changes in the average diastolic blood pressure of ambulatory blood pressure during the daytime, at night and over 24 hours after the operation