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Sound waves to the kidneys: a new hope for blood pressure control?

NCT ID NCT06194591

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether gentle shockwaves applied to the kidneys can lower blood pressure in people with chronic kidney disease. Thirty adults with high blood pressure and moderate-to-severe kidney disease will receive either real or fake (sham) treatments over three weeks. The goal is to see if this painless, non-invasive procedure can safely reduce blood pressure and possibly improve kidney function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low-intensity extracorporeal shockwave therapy (Li-ESWT) via NephrospecTM device
What this could lead to
If it works, this could offer a non-drug way to lower blood pressure and possibly slow kidney decline in people with chronic kidney disease.
What could go wrong
This is a small early-stage trial with only 30 people, so results may not apply widely. The treatment is still experimental and may not improve blood pressure or kidney function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 82 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Nephrology, Centre Hospitalier Universitaire Vaudois

    RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

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