Zapping kidney nerves: a new way to tackle stubborn high blood pressure?
NCT ID NCT03614260
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
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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
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224 people
The number who actually took part.
- Started
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Dec 2018
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
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CHRU de Lille
Lille, 59000, France
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Cardiology PC
Birmingham, Alabama, 35211, United States
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Cedars Sinai Medical Center
Los Angeles, California, 940048, United States
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Centre Hospitalier Universitaire Saint-Pierre
Brussels, 1000, Belgium
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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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
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Erasmus Medical Center
Rotterdam, 3015 GD, Netherlands
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Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
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Hackensack University
Hackensack, New Jersey, 07601, United States
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Herzzentrum Leipzig GmbH
Leipzig, D-04289, Germany
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Hôpital Européen Georges-Pompidou (HEGP)
Paris, 75015, France
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Hôpital Saint André
Bordeaux, 33000, France
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Hôpitaux Universitaires Genève
Geneva, 1211, Switzerland
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Kent & Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
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Klinikum Karlsruhe GmbH
Karlsruhe, 76133, Germany
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Klinikum Konstanz
Konstanz, D-78464, Germany
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MedStar Washington
Washington D.C., District of Columbia, 20010, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
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Munson Medical Center
Traverse City, Michigan, 49684, United States
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Northwell Health Inc.
New York, New York, 10075, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Ochsner Heart and Vascular Institute
New Orleans, Louisiana, 70121, United States
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Renown Regional Medical Center
Reno, Nevada, 89502, United States
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Saint Luke's Health System
Kansas City, Missouri, 64111, United States
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Sana Kliniken Lübeck GmbH
Lübeck, D-23560, Germany
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Southern Illinois University
Springfield, Illinois, 62794, United States
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St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
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Stamford Hospital
Stamford, Connecticut, 06904, United States
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Swedish Medical Center
Seattle, Washington, 98122, United States
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The Brigham and Women's Hospital
Boston, Massachusetts, 02120, United States
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The Cardiac and Vascular Institute
Gainsville, Florida, 32605, United States
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The Cardiothoracic Centre Basildon University Hospital
Basildon, Essex, SS16 5NL, United Kingdom
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The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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The University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
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University Clinic Erlangen
Erlangen, D-91054, Germany
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University Clinic of Saarland - Homburg
Homburg, D-66421, Germany
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University Hospital Galway
Galway, H91 YR71, Ireland
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University Hospital Wales
Cardiff, United Kingdom
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University Hospitals Dorset NHS Foundation Trust
Bournemouth, BH7 7DW, United Kingdom
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University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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University of Utah
Salt Lake City, Utah, 84132, United States
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Vanderbilt University
Nashville, Tennessee, 37232, United States
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