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Could zapping kidney nerves tame tough high blood pressure?

NCT ID NCT05198674

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 13 times

Summary

This study tests a device that uses radiofrequency energy to calm overactive kidney nerves, which can drive high blood pressure. About 1,900 adults with uncontrolled hypertension will receive the procedure and be followed for years. The goal is to see if this approach safely and durably lowers blood pressure, potentially reducing the need for lifelong medication.

What this could mean

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

Active substance
Symplicity Spyral renal denervation system (a device that delivers radiofrequency energy to kidney nerves)
What this could lead to
If successful, this could offer a long-term, drug-free option to help control high blood pressure, reducing the risk of heart disease and stroke.
What could go wrong
This is a single-arm study without a placebo group, so results may be less definitive. The procedure carries risks like bleeding or damage to kidney arteries, and not everyone may respond.

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

1,899 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Nov 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 years and older

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. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg 2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg 3. Individual has an average systolic baseline home blood pressure ≥135 mmHg Exclusion Criteria: 1. Individual lacks appropriate renal artery anatomy 2. Individual has undergone prior renal denervation 3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement 4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea 5. Individual has an estimated glomerular filtration rate (eGFR) of \<45 6. Individual has one or more episode(s) of orthostatic hypotension 7. Individual is pregnant, nursing or planning to become pregnant 8. Individual has primary pulmonary hypertension 9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%

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Get notified about this study

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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

  • AZ Sint Jan Brugge-Oostende av

    Bruges, 8000, Belgium

  • Abrazo Arizona Heart Hospital/Biltmore Cardiology

    Phoenix, Arizona, 85016, United States

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Advocate Aurora Health-Aurora St. Luke's Medical Center (ASLMC)

    Milwaukee, Wisconsin, 53215, United States

  • Algemeen Stedelijk Ziekenhuis - R&D Hartziekten

    Aalst, Oost - Vlaanderen, 9300, Belgium

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • AnMed Health Medical Center

    Anderson, South Carolina, 29621, United States

  • Arkansas Cardiology

    Little Rock, Arkansas, 72205, United States

  • Banner Heart Hospital

    Mesa, Arizona, 85206, United States

  • Baptist Medical Center

    Jacksonville, Florida, 32207, United States

  • BayCare Health System

    Clearwater, Florida, 33756, United States

  • BayCare Medical Group

    Safety Harbor, Florida, 34695, United States

  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital

    Dallas, Texas, 75226-1316, United States

  • Baylor Scott & White The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota, 56303-1900, United States

  • Centre Hospitalier Princesse Grace

    Monaco, 98000, Monaco

  • Chc Montlegia

    Liège, 4000, Belgium

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Colorado Heart and Vascular PC

    Lakewood, Colorado, 80228, United States

  • DHR Health Institute for Research and Development

    Edinburg, Texas, 78539, United States

  • Danderyd Sjukhus

    Stockholm, 18288, Sweden

  • Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03756, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Erasmus Universtiy Medical Center

    Rotterdam, Netherlands

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Heart Care Centers of Illinois

    Palos Park, Illinois, 60464, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Henry Ford Providence Southfield Hospital

    Southfield, Michigan, 48075, United States

  • Henry Ford Saint John Hospital

    Detroit, Michigan, 48236, United States

  • Herzzentrum Leipzig

    Leipzig, 04289, Germany

  • Hippokration General Hospital of Athens

    Athens, 11527, Greece

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Hôpital Pitié Salpêtrière

    Paris, 75013, France

  • Hôpital Saint André -Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33 000, France

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • John Radcliffe Hospital

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Justus-Liebig-Universität Gießen

    Giessen, 35390, Germany

  • Loyola University Medical Center

    Maywood, Illinois, 60153-3328, United States

  • Mater Misericordiae University Hospital

    Dublin, Dublin, D07 R2WY, Ireland

  • MedStar Washington Hospital Center

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

  • Mercy Medical Center

    West Des Moines, Iowa, 50266-8209, United States

  • Methodist Hospital

    San Antonio, Texas, 78229, United States

  • Metropolitan Heart and Vascular Institute (MHVI)

    Coon Rapids, Minnesota, 55433, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120, United States

  • Orlando Health Heart & Vascular Institute

    Orlando, Florida, 32806, United States

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201, United States

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • Royal Perth Hospital (Dobney Hypertension Centre)

    Perth, Western Australia, 6000, Australia

  • SJH Cardiology Associates

    Liverpool, New York, 13088, United States

  • Saint Francis Hospital

    Roslyn, New York, 11576-1348, United States

  • Saint Joseph Medical Center (Towson MD)

    Towson, Maryland, 21204, United States

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341, United States

  • Sana Kliniken Lübeck GmbH

    Lübeck, 23560, Germany

  • Sanford Medical Center

    Fargo, North Dakota, 58102, United States

  • Scripps Memorial Hospital

    La Jolla, California, 92037, United States

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503-2560, United States

  • St. Vincents Hospital

    Indianapolis, Indiana, 46290, United States

  • Stanford Hospital and Clinics

    Stanford, California, 94305, United States

  • Tallahassee Memorial Healthcare, Inc

    Tallahassee, Florida, 32308, United States

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • The Lindner Center

    Cincinnati, Ohio, 45219, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • The University of Texas at Tyler

    Tyler, Texas, 75701, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

  • UPMC Harrisburg Hospital

    Harrisburg, Pennsylvania, 17101, United States

  • UVA Medical Center

    Charlottesville, Virginia, 22908, United States

  • Uniklinik Erlangen

    Erlangen, 91054, Germany

  • Universitatsklinikum des Saarlandes

    Homburg, Germany

  • University Hospital Ghent

    Ghent, 9000, Belgium

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham (UAB) Hospital

    Birmingham, Alabama, 35233, United States

  • University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Miami Hosptial

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virtua Medical Group

    Marlton, New Jersey, 08053, United States

  • Weill Cornell Medical Center

    New York, New York, 10021-9800, United States

  • Wellstar Research Institute

    Marietta, Georgia, 30060, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

  • Ziekenhuis Oost Limburg - Campus Sint-Jan

    Genk, 3600, Belgium

  • Zuyderland Medisch Centrum Heerlen

    Heerlen, 6419 PC, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.