Zapping kidney nerves: a new way to tackle stubborn high blood pressure?

NCT ID NCT03614260

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time

Summary

Researchers are testing whether a catheter-based procedure called renal denervation can lower blood pressure in people with stage 2 hypertension. The procedure uses ultrasound energy to calm overactive nerves around the kidney arteries. Participants receive either the active treatment or a sham procedure, and researchers compare changes in daytime blood pressure after two months. The trial also tracks safety events such as death, kidney failure, and major cardiovascular problems.

What this could mean

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

Active substance
Renal denervation using the Paradise System, a catheter-based procedure that delivers ultrasound energy to nerves around the kidney arteries
What this could lead to
If it works, this could offer a device-based option for people whose stage 2 hypertension is not controlled by lifestyle changes or a limited number of medications.
What could go wrong
The procedure is invasive and carries risks such as bleeding or damage to the kidney arteries. The trial is relatively small, and blood pressure lowering may not last or may not translate into fewer heart attacks or strokes.

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

224 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Jul 2029

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

18 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: * Previously or currently prescribed antihypertensive therapy * Average office BP ≥ 140/90 mmHg \<180/120 mmHg while stable for at least 4 weeks on 0-2 classes of antihypertensive medication * Documented daytime ABP ≥ 135/85 mmHg and \< 170/105 mmHg after 4-week washout/run-in period Exclusion Criteria: * Lacks appropriate renal artery anatomy for treatment * Known, uncorrected causes of secondary hypertension other than sleep apnea * Type I diabetes mellitus or uncontrolled Type II diabetes * eGFR of \<40 * Brachial circumference ≥ 42 cm * Any history of cerebrovascular event or severe cardiovascular event, or history of stable or unstable angina within 12 months prior to consent * Repeat (\>1) hospitalization for hypertensive crisis within 12 months prior to screening period, or any hospitalization for hypertensive crisis within 3 months prior to screening period * Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea * Primary pulmonary hypertension * Night shift workers * Pregnant, nursing or planning to become pregnant

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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.

Contacts and locations

Locations

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610, United States

  • CHRU de Lille

    Lille, 59000, France

  • Cardiology PC

    Birmingham, Alabama, 35211, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 940048, United States

  • Centre Hospitalier Universitaire Saint-Pierre

    Brussels, 1000, Belgium

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center/NYPH

    New York, New York, 10032, United States

  • Deborah Heart & Lung Center

    Browns Mills, New Jersey, 08015, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Erasmus Medical Center

    Rotterdam, 3015 GD, Netherlands

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Hackensack University

    Hackensack, New Jersey, 07601, United States

  • Herzzentrum Leipzig GmbH

    Leipzig, D-04289, Germany

  • Hôpital Européen Georges-Pompidou (HEGP)

    Paris, 75015, France

  • Hôpital Saint André

    Bordeaux, 33000, France

  • Hôpitaux Universitaires Genève

    Geneva, 1211, Switzerland

  • Kent & Canterbury Hospital

    Canterbury, CT1 3NG, United Kingdom

  • Klinikum Karlsruhe GmbH

    Karlsruhe, 76133, Germany

  • Klinikum Konstanz

    Konstanz, D-78464, Germany

  • MedStar Washington

    Washington D.C., District of Columbia, 20010, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Munson Medical Center

    Traverse City, Michigan, 49684, United States

  • Northwell Health Inc.

    New York, New York, 10075, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ochsner Heart and Vascular Institute

    New Orleans, Louisiana, 70121, United States

  • Renown Regional Medical Center

    Reno, Nevada, 89502, United States

  • Saint Luke's Health System

    Kansas City, Missouri, 64111, United States

  • Sana Kliniken Lübeck GmbH

    Lübeck, D-23560, Germany

  • Southern Illinois University

    Springfield, Illinois, 62794, United States

  • St Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

  • Stamford Hospital

    Stamford, Connecticut, 06904, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • The Brigham and Women's Hospital

    Boston, Massachusetts, 02120, United States

  • The Cardiac and Vascular Institute

    Gainsville, Florida, 32605, United States

  • The Cardiothoracic Centre Basildon University Hospital

    Basildon, Essex, SS16 5NL, United Kingdom

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • The University of Tennessee Health Science Center

    Memphis, Tennessee, 38163, United States

  • University Clinic Erlangen

    Erlangen, D-91054, Germany

  • University Clinic of Saarland - Homburg

    Homburg, D-66421, Germany

  • University Hospital Galway

    Galway, H91 YR71, Ireland

  • University Hospital Wales

    Cardiff, United Kingdom

  • University Hospitals Dorset NHS Foundation Trust

    Bournemouth, BH7 7DW, United Kingdom

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

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