Sound waves to zap hypertension? new trial tests ultrasound treatment

NCT ID NCT06559891

Disease control Sponsor: SoniVie Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Sep 03, 2026 · Updated 8 times

Summary

This study tests a device that uses ultrasound to calm overactive nerves in the kidneys, which can drive high blood pressure. About 261 adults with hypertension will either get the real procedure or a sham (fake) one. The goal is to see if this approach safely lowers blood pressure, possibly reducing the need for daily medication.

What this could mean

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

Active substance: ultrasound energy delivered via a catheter to nerves around the kidney arteries
What this could lead to: If it works, this could offer a new, drug-free option to help control high blood pressure without daily pills.
What could go wrong: This is an early-stage device trial with only 261 participants. The procedure involves risks like blood vessel damage, and it may not lower blood pressure enough to replace medication.

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 261 people

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

Started

Oct 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

22 to 75 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: 1. Appropriately signed and dated informed consent 2. Male and female adults with age between ≥22 and ≤75 years at time of consent 3. Documented history of hypertension 4. Previously or currently prescribed antihypertensive therapy 5. Subject has an office BP (average of 3 seated measurements) of: 1. Uncontrolled BP: ≥ 140/90 mmHg \<180/110 mmHg at Screening Visit (V0) while stable for at least 4 weeks on 0-2 anti-hypertensive medications of different classes\* and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure, (subjects with a history of treatment with anti-hypertensive medications but are not currently taking any at screening will undergo a 4-week run-in period) or, 2. Controlled BP: \< 140/90 mmHg while stable for at least 4 weeks on 1-2 antihypertensive medications of different classes and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure 6. Able and willing to comply with all study procedures 7. Subject is willing to have and is a good candidate for conscious sedation Subjects who meet the following criteria will be considered eligible for randomization: * Documented daytime systolic ABP ≥ 135 mmHg and \< 180 mmHg after 4-week washout/run-in period.\*\* * Suitable renal anatomy compatible with the renal denervation procedure, documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in subjects without a recent (≤1 year) cross-sectional renal imaging). The renal angiogram procedure done in the cath lab prior to randomization will serve as the final anatomy compatibility check. * Potassium-sparing diuretics such as Amiloride hydrochloride and Triamterene may be prescribed in combination with another diuretic (e.g. a thiazide or loop diuretic) for their potassium conservation properties. In this situation, the diuretic combination is considered as a single class of anti-hypertensive. Exclusion Criteria: 1. Subject has been previously diagnosed with abnormal renal artery anatomy and/or renal anatomy such as a single kidney, ectopic or horseshoe kidney, polycystic kidney disease, kidney tumors or other findings precluding renal denervation therapy as detailed in the angiographic exclusion criteria 2. Uncorrected causes of secondary hypertension other than sleep apnea (including, but not limited to): aldosteronism, renal parenchymal disease, renovascular disease, excess catecholamines, Cushing's syndrome, erythropoietin use, pheochromocytoma, hypo/hyperthyroidism, hyperparathyroidism, acromegaly) 3. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥ 9.0%) 4. eGFR of \<40 mL/min/1.73 m2 CKD-EPI as calculated using the CKD-EPI 2021 equation 5. Cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 6 months prior to consent 6. History of severe cardiovascular event (e.g. myocardial infarction, unstable angina, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 12 months prior to consent 7. Subject has severe valvular stenosis or insufficiency 8. Documented repeat (\>1) hospitalization for hypertensive crisis within the prior 12 months and/or any hospitalization for hypertensive crisis within three (3) months prior to consent 9. Prescribed to any standard antihypertensive cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health in the opinion of the investigator 10. Subject with rapid, uncontrolled, symptomatic atrial fibrillation 11. Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator) 12. Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea. 13. Subject has a planned major surgery (any procedure requiring general anesthesia) in the next 12 months. 14. Subject on anticoagulant therapy that cannot be temporarily withheld for study procedure. 15. Primary pulmonary hypertension 16. Documented contraindication or allergy to contrast medium not amenable to treatment 17. Limited life expectancy of \< 1 year at the discretion of the Investigator 18. Night shift worker 19. Subject has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment. 20. Subject is taking immunosuppressive therapy for diseases featuring vasculitis 21. Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders 22. Pregnant, nursing or planning to become pregnant within 12 months post procedure. Negative pregnancy test required, documented within a maximum of 7 days prior to procedure for all women of childbearing potential. Documentation of effective contraception is also required for women of childbearing potential 23. Subject has a planned major surgery or cardiovascular intervention in the next 6 months 24. Subject with history of renal transplantation 25. Evidence of active infection within 7 days of procedure (based on positive lab test and requiring therapy). 26. Subject has hypertrophic cardiomyopathy or amyloidosis. 27. Prior renal denervation procedure 28. Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional studies/registries is acceptable) 29. Subject on a beta blocker for a condition other than antihypertension Angiographic Exclusion Criteria: The following characteristics identified either on the renal artery CT scan or MRI or on the Eligibility II Renal artery Angiogram will prevent the subject from being included: 1. Main renal arteries lumen diameter \< 4 mm. 2. Main renal treatable artery length \<20mm (may include proximal branching). 3. Accessory renal arteries that supplies ≥ 25% of the parenchyma, and \< 4 mm in lumen diameter. 4. Aorto-renal angle that prevents a safe cannulation of the renal artery. 5. Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the TIVUS™ procedure. 6. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, would interfere with safe cannulation of the renal artery or meets local standards for surgical repair or interventional dilation (NOTE: vessel areas with calcification and fibromuscular dysplasia (FMD) should be avoided as intended treatment areas). 7. Any renal artery stenosis \> 30% by visual assessment. 8. Any renal artery aneurysm (\>50% of the main renal artery reference vessel diameter by visual estimate). 9. Presence of fibromuscular dysplasia of the renal arteries 10. Significant renal artery atheroma, aneurysm, calcification in the target vessel identified on CT Angiogram

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Conditions

The condition(s) this trial relates to.

hypertensive disorder

As listed by the trial registrant

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

Hypertension

How to take part

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

The places running it

50 sites in 5 countries. The list below names each one and where it is.
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 ↗
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

Arkansas Heart Hospital
RECRUITING

Little Rock, Arkansas, 72211, United States
Ascension Alexian Brothers
RECRUITING

Elk Grove Village, Illinois, 60007, United States
Ascension St. John Clinical Research Institute
RECRUITING

Bartlesville, Oklahoma, 74006, United States
Ascension- Sacred Heart
RECRUITING

Pensecola, Florida, 32504, United States
Athens Hippokration
RECRUITING

Athens, Greece
Cardiology, PC
RECRUITING

Birmingham, Alabama, 35211, United States
Cardiovascular Institute of the South
RECRUITING

Houma, Louisiana, 70360, United States
Cedar-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Chippenham Hospital
RECRUITING

Richmond, Virginia, 23225, United States
Clinica Montevergine
RECRUITING

Mercogliano, Italy
Connecticut Clinical Research, LLC (Bridgeport)
RECRUITING

Bridgeport, Connecticut, 06610, United States
Dresden TUD University of Technology
RECRUITING

Dresden, Germany
Frankfurt Sankt Katharinen Krankenhaus
RECRUITING

Frankfurt, Germany
Freiburg Herzzenrtum
RECRUITING

Freiburg im Breisgau, Germany
Gulfport Memorial Hospital
RECRUITING

Gulfport, Mississippi, 39501, United States
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States
Henry Ford Providence Hospital
RECRUITING

Southfield, Michigan, 48075, United States
Herne Marien Hospital
RECRUITING

Herne, Germany
Herzzentrum Leipzig
RECRUITING

Leipzig, Germany
HonorHealth
RECRUITING

Scottsdale, Arizona, 85258, United States
Hopital Saint André
RECRUITING

Bordeaux, France
Houston Medical Center
RECRUITING

Houston, Texas, 77004, United States
Hôpital Européen Georges-Pompidou
RECRUITING

Paris, France
Jackson Heart Clinic
RECRUITING

Jackson, Mississippi, 39216, United States
Jersey Shore University Medical Center
RECRUITING

Neptune City, New Jersey, 07753, United States
Lancaster General Health
RECRUITING

Lancaster, Pennsylvania, 17603, United States
MUSC
RECRUITING

Mt. Pleasant, South Carolina, 29464, United States
Marienkrankenhaus Hamburg
RECRUITING

Hamburg, Germany
Monza Policlinico
RECRUITING

Monza, Italy
NC Heart and Vascular
RECRUITING

Raleigh, North Carolina, 27607, United States
Nyph/Cumc
RECRUITING

New York, New York, 10032, United States
Ochsner Medical Center
RECRUITING

New Orleans, Louisiana, 70121, United States
Ospedale Sant'Andrea
RECRUITING

Roma, Italy
Penn Medicine
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Plaza Medical Center of Fort Worth
RECRUITING

Fort Worth, Texas, 76104, United States
Renown Regional Medical Center
RECRUITING

Reno, Nevada, 89502, United States
Saarland University Hospital
RECRUITING

Homburg, Germany
Sana Kliniken Lubeck
RECRUITING

Lübeck, Germany
Southern Illinois University, School of Medicine
RECRUITING

Springfield, Illinois, 62794, United States
St Lukes Hospital
RECRUITING

Kansas City, Missouri, 64131, United States
St Marks Hospital
RECRUITING

Salt Lake City, Utah, 37027, United States
St. Bernard's Medical Center
RECRUITING

Jonesboro, Arkansas, 72401, United States
St. John's Prairie Heart
RECRUITING

Springfield, Illinois, 62710, United States
St. Joseph
RECRUITING

Liverpool, New York, 13088, United States
Stanford University
RECRUITING

Palo Alto, California, 94305, United States
Thessaloniki Hippokration General Hospital
RECRUITING

Thessaloniki, Greece
University of Crete
RECRUITING

Heraklion, Greece
University of South Florida
RECRUITING

Tampa, Florida, 33606, United States
Universitätsklinikum Erlangen
RECRUITING

Erlangen, Germany
Virtua Health
RECRUITING

Camden, New Jersey, 08103, United States

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