Actively Recruiting
Nephrospec Switzerland
Led by Menno Pruijm · Updated on 2026-01-23
30
Participants Needed
1
Research Sites
279 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Nephrospec Switzerland
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 82 years
- Diagnosed with hypertension with systolic blood pressure ≥135 mmHg on stable medical treatment for over 60 days
- Moderate to severe chronic kidney disease with eGFR 20-70 mL/min/1.73m2 on stable medical therapy
- Or eGFR 60-90 mL/min/1.73m2 with albuminuria ≥30 mg/mmol in spot urine or ≥300 mg/day in 24-hour urine
- Able and willing to comply with follow-up schedule
- Capable of giving informed consent
You will not qualify if you...
- Systolic blood pressure over 180 mmHg despite stable medication at maximum tolerated dose
- Hypertension secondary to treatable causes other than renal artery stenosis or CKD
- History of renal artery stent or other renal artery interventions including denervation
- Kidney conditions: eGFR below 20 mL/min/1.73m2, dialysis, kidney transplant, active pyelonephritis, kidney stones, polycystic kidney disease, complicated renal cysts (Bosniak III or higher)
- Symptomatic macrohematuria with hemoglobin drop over 2 grams
- Hemoglobin ≤9 grams per deciliter
- Bleeding disorders or abnormal coagulation tests (INR > 2.5, abnormal PT, PTT, platelet count)
- Recent (less than 6 months) heart attack, PCI, stroke, or hospitalization for heart failure with reduced ejection fraction
- Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c > 10%)
- Active cancer at or near treatment area
- Recent immunosuppression (last 3 months), chronic oxygen or mechanical ventilation support (except sleep apnea)
- Local skin infection at treatment site
- Allergy to SonoVue contrast or contraindications to its use
- Contraindications to MRI (e.g., pacemaker, severe claustrophobia)
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Known or suspected non-compliance, drug or alcohol abuse
- Night shift workers
- Pregnant, breastfeeding, or planning pregnancy
- Unwilling to be informed of accidental health findings during the study
- Participation in other investigational drug/device studies within 30 days
- Previous enrollment in this study
- Investigator or related persons involved in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Nephrology, Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
M
Menno Pruijm, Dr
CONTACT
W
Wendy Brito
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here