Low-intensity shock wave therapy for chronic kidney disease and hypertension
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
This study is testing if low-intensity shock wave therapy can help people with high blood pressure and chronic kidney disease feel better and improve their kidney function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 82 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT06194591 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of low-intensity extracorporeal shock wave therapy (Li-ESWT) on patients with hypertension and moderate to severe chronic kidney disease. A total of 30 participants will be randomized into either an active treatment group receiving Li-ESWT or a sham group. The treatment will be administered over three consecutive weeks, followed by a 48-week follow-up to assess changes in blood pressure, renal function, perfusion, and oxygenation. Additionally, a third arm will provide treatment to those who did not improve in the sham group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with hypertension and moderate to severe chronic kidney disease who are stable on their current medication.
Not a fit: Patients with uncontrolled hypertension (systolic BP over 180 mmHg) or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved blood pressure control and renal function in patients with chronic kidney disease.
How similar studies have performed: Previous studies have shown promising results with Li-ESWT in improving renal function and reducing blood pressure in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18 years to 82 years. * Patient is diagnosed with Hypertension, i.e. home,office and/or 24h systolic blood pressure ≥135 mmHg (as per ISH guidelines, 2020), currently on stable (over 60 days) medical therapy as prescribed by a physician, of none, one, or more antihypertensive medication classes. Patients will be considered stable if no relevant medication change for over 60 days or for 30 days if there were no previous changes 90 days before the current change. * Patients diagnosed with moderate to severe chronic renal failure (eGFR 20-70 mL/min/1.73m2) who are currently on stable medical therapy as prescribed by a physician. * Patients with eGFR between 60-90 ml/min/1.73m2 and albuminuria \>=30mg/mmol in spot urine or \>=300mg/day in 24h urine collection * Patient is able and willing to comply with the required follow-up schedule. * Patient is capable of giving an informed consent. Exclusion Criteria: * Hypertension: Individual's systolic BP is over 180mmHg when receiving stable medical medication regimen as prescribed by a physician, of none, one, or more antihypertensive medication classes at maximally tolerated dose. Hypertension secondary to an identifiable and treatable cause, other than Renal artery stenosis or CKD, or is prescribed a medication that may raise BP. * History of previous renal artery stent. Stent or other intervention involving renal arteries including but not limited to renal denervation procedures. * Kidney conditions non compatible with the study: Patient has an eGFR \<20 ml/min/1.73m², is on Dialysis or has had a kidney transplant performed. Active pyelonephritis. History of or current kidney stones. Patients with polycystic kidney disease or a known complicated renal cyst (Bosniak III or higher). * Symptomatic patients (Macrohematuria) with a decrease of over 2 grams in Hb. * Hemoglobin (Hb) ≤ 9 grams per deciliter (blood). * Coagulation issues: Bleeding tendency resulting from hematologic disease. Subjects having INR \> 2.5 and PT, PTT and platelet count which deviates from the clinical laboratory normal reference range. * Diseases non compatible with the study: Recent (less than 6 months) history of myocardial infarction, PCI, stroke or hospitalization for HFrEF (heart failure with reduced ejection fraction). Individual has type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c \> 10%). * Active Cancer - primary tumor or metastatic, such as liver, renal, testicular, abdominal tumor or local tumor at treatment area.. * Treatment non compatible with the study: Patients that have been treated with immunosuppression in the last 3 months. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. No change in dosing of RAS inhibitors in the month prior to the procedure is required. * Technical impossibility to participate: Local infection of the skin at the area to be in contact with the applicator. * Known allergy to Sonovue® contrast product (hypersensibility to sulfur hexyfluoride or another component). * No other contraindication to SonoVue, ie. patients with right-to-left shunts, severe pulmonary hypertension (pulmonary arterial pressure \> 90 mm Hg), uncontrolled systemic hypertension and in adult patients with respiratory distress syndrome (ARDS). * Contraindication to undergo MR-imaging such as the presence of a pacemaker or other implanted metallic device or severe claustrophobia. * Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject/ Unable to obtain consent * Known or suspected non-compliance, drug or alcohol abuse * Individual works night shifts. * Individual is pregnant, breast feeding or planning to become pregnant. * Individual does not want to be informed in case of accidental finding related to individual's health discovered during imaging or other study-related exams. * Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation, * Previous enrolment into the current investigation, * Enrolment of the PI, his/her family members, employees, and other dependent persons
Where this trial is running
Lausanne, Canton of Vaud
- Department of Nephrology, Centre Hospitalier Universitaire Vaudois — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Menno Pruijm, Dr — Chuv
- Study coordinator: Menno Pruijm, Dr
- Email: menno.pruijm@chuv.ch
- Phone: +41 (0)21 314 13 58
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.