Study on the effectiveness and benefit of low-intensity shock wave treatment using the Nephrospec medical device on hypertension and renal function in patients with chronic kidney disease

Zusammenfassung der Studie

The present study aims to confirm the potential beneficial effect of low-intensity acoustic wave therapy (OCBI) on blood pressure control and renal function for patients with chronic kidney disease (CKD). This low-intensity acoustic wave therapy, previously used to treat muscle pain or chest pain in patients with heart disease, is also capable of stimulating kidney tissues. This therapy is a modification of a treatment used for over forty years to fragment kidney stones with shock waves. The proposed therapy consists of administering shock waves at a much lower intensity (over 20 times weaker) than those applied in the case of kidney stones. Previous studies have shown that this therapy lowers blood pressure and stabilizes kidney function in patients with diabetes and CKD, but the mechanism of action remains unclear. These results need to be confirmed in a larger number of patients with CKD, with or without diabetes. The aim of our study is also to find out whether low-intensity shock waves increase perfusion (i.e., the amount of blood flowing through the kidneys) and the degree of oxygenation of the kidneys. Our center has very modern imaging techniques such as microbubble ultrasound and functional magnetic resonance imaging that are capable of capturing changes in kidney perfusion and oxygenation without administering potentially toxic substances to the kidneys.

(BASEC)

Untersuchte Intervention

This is a randomized double-blind study (explanation below). 2/3 of the 30 participants will receive acoustic wave therapy (OCBI), and 1/3 a placebo therapy (a "fake" treatment without therapeutic effect to compare the results obtained). Assignment to one group or another is done randomly, by lottery (randomized). Participants in the 'treatment' arm will receive 6 sessions of OCBI treatment in the Nephrology department. The waves will be administered by a probe (OmnispecTM, Model NephrospecTM) that is placed on the skin and locally sends low-intensity shock waves under ultrasound guidance. The sessions (duration: 30-60 minutes per session) will take place twice a week for three weeks. Patients in the placebo arm will also receive 6 treatment sessions with the same probe (Nephrospec), but this time, the acoustic waves administered to the placebo group will be blocked by a membrane and will not have any effect on the kidneys. Neither the investigators nor the patients will know which group the participants have been assigned to (double-blind). In case of participation in the placebo arm during phase A and no improvement in the disease, patients may participate in phase B of the study, in which 6 additional sessions of OCBI will be administered. In phase B, all sessions will be active treatment sessions. Success is defined as: 1) a reduction of 5 points (in mmHg) in systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring, 2) stabilization or improvement of estimated glomerular filtration rate (GFR, the volume of fluid filtered by the kidney per unit time), 3) stabilization or reduction of albuminuria measured in a urine sample (the presence of the protein "albumin").

(BASEC)

Untersuchte Krankheit(en)

Patients suffering from chronic kidney disease with an estimated glomerular filtration rate (% of kidney function) between 20-60 ml/min/1.73m² (20-60%) and hypertension (systolic blood pressure between 140 and 180 mmHg).

(BASEC)

Sponsor

Centre hospitalier universitaire vaudois, CHUV, Lausanne Sponsor representative: Menno Pruijm

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Waadt

(BASEC)

Datum der Bewilligung durch die Ethikkommission

09.11.2023

(BASEC)

Ergebnisse der Studie