Nephrospec Switzerland

Hypertension Clinical Trial

Official title: Low-intensity Extracorporeal Shockwave Therapy With the Nephrospec TM Device for the Treatment of Hypertension in Patients Diagnosed With Chronic Kidney Disease (CKD) : a Randomized, Double-blind Sham-controlled Monocentric Trial

Status Recruiting

Clinical Trial Summary

This is a randomized, double-blind sham-controlled monocentric trial. 30 patients that are diagnosed with hypertension and with moderate to severe chronic kidney disease are included in this trial. 20 of them are randomized into the active treatment arm, 10 into the sham arm. Low-intensity extracorporal shock wave (Li-ESWT) sessions (arm1) or sham sessions (arm2), will be administered with a dedicated probe within three consecutive weeks to the kidneys of patients.The study will add data to the effects of the shock wave treatment on blood pressure and will assess whether this treatment improves renal function, perfusion and oxygenation. The study includes a third arm (arm3) in which treatment sessions are administered to patients that were in the placebo group in the first phase of the study (arm2).

Clinical Trial Description

This is a randomized, double-blind sham-controlled monocentric trial. Adult patients that are diagnosed with hypertension (systolic blood pressure 140 - 180 mmHg), currently on stable (over 60 days) medical therapy and with moderate to severe chronic kidney disease (eGFR 20-60 mL/min/1.73m2) who are currently on stable (at least 60 days) medical therapy are included in this trial.

20 patients are randomized into the active treatment arm with the investigational medical device, 10 patients into the sham arm. Low-intensity extracorporal shock wave (Li-ESWT) sessions (arm1) with a dedicated probe (Nephrospec device) or sham sessions (arm2), within three consecutive weeks, will be applied to the kidneys of patients. Patients will be followed-up for 48 weeks after the treatment.The study includes a third arm (arm3) in which treatment sessions are administered to patients that were in the placebo group in the first phase of the study and for whom their condition did not improve (arm 2).

Low-intensity extracorporeal shockwave therapy (Li-ESWT) is based on the classic technique of lithotripsy for the extracorporeal treatment of kidney stones but applied at much lower intensity (~10%). Previous histological studies in animals have shown that Li-ESWT has favourable effects on kidney perfusion and oxygenation. In human studies that included patients with diabetic nephropathy, six to twelve sessions of Li-ESWT lead to long-term reduction of blood pressure and stabilization of renal function (eGFR). The medical device Nephrospec TM is CE-mark and used in the ambulatory setting to lower BP in patients with CKD. The device will be used according to the instructions and indications mentioned in the operator manual.

The primary outcome of this trial is the change in systolic 24-hour ambulatory blood pressure (ABPM) from baseline to 12 weeks post treatment. Further important secondary ouctomes are automatic office blood pressure (AOBP), the change in number or dose of blood pressure medications, the change in eGFR and the change in albumine/creatinine ratio (ACR). Furthermore, the study will assess whether the treatment improves renal function, Contrast enhanced ultrasound (CEUS)-assessed perfusion index, as well as renal oxygenation and fibrosis (ADC) assessed by MRI. ;

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT06194591
• Study type: Interventional
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Menno Pruijm, Dr
• Phone: +41 (0)21 314 13 58
• Email: menno.pruijm@chuv.ch
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Completion date: June 30, 2026