Objective: Arterial hypertension (AHT) is very common in chronic kidney disease (CKD) patients. Low-intensity extra-corporal shock wave therapy (LI-ESWT) holds potential as a non-pharmaceutical treatment of AHT in preclinical studies. The aim of this randomized, sham-controlled, double-blind study is to assess whether LI-ESWT lowers blood pressure (BP) and stabilizes kidney function in CKD patients. As secondary aims, the study investigates whether LI-ESWT improves kidney micro-perfusion, oxygenation and fibrosis as measured with contrast-enhanced ultrasound (CEUS) and magnetic resonance imaging (MRI).Design and method: A total of six LI-ESWT treatments of one hour each are administered to 30 CKD patients (eGFR 20-90 ml/min/1.73m2) in the ambulatory setting over a three-week period; 20 patients are randomized to active treatment, 10 are treated with a sham probe. Office blood pressure (BP), 24 h ambulatory BP, blood and urine sampling are performed at baseline, 12, 24 and 48 weeks post treatment. CEUS and MRI are performed at baseline and three months after the last treatment. Multiparametric MRI includes blood-oxygenation level dependent (BOLD) and diffusion weighted MRI to measure respectively kidney oxygenation (R2*) and degree of fibrosis (delta ADC). Results: Thus far, 18 out of the planned 30 patients have been enrolled. A total of 2 patients have KDIGO stage G2, 10 stage G3 and 6 stage G4 CKD. Causes of CKD are diabetes mellitus (11/18), hypertension (6/8) and IgA nephropathy (1). Clinical and imaging characteristics are shown in the table. LI-ESWT was successfully administered to all patients and well tolerated; no treatment-related serious adverse events have occurred. CEUS-assessed perfusion index (PI) has been measured in all patients, whereas 3 MRIs had to be excluded because of insufficient quality. Conclusions: LI-ESWT is well-tolerated, without SAE or specific AE reported thus far, and can be easily administered in the ambulatory setting to hypertensive patients with CKD. CEUS-assessed PI and MRI-assessed R2* levels indicate respectively low micro-perfusion and oxygenation at baseline; the negative delta ADC levels suggest high degrees of fibrosis. The effects on BP, kidney function, metabolism and micro-structure will be reported after unblinding at the end of the study.
Pruijm et al. (Fri,) studied this question.