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SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System

NCT ID: NCT02439775

Last Updated: 2025-11-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-22

Study Completion Date

2025-08-14

Brief Summary

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The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.

Detailed Description

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The purpose of this study is to test the hypothesis that renal denervation is safe and reduces systolic blood pressure (SBP) in patients with uncontrolled hypertension on one, two, or three standard antihypertensive medications compared to a sham control in the same population. In this study, "uncontrolled hypertension" is defined as an office systolic blood pressure (SBP) ≥ 150 mmHg and \<180 mmHg, an office Diastolic Blood Pressure (DBP) ≥90 mmHg and a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥140 mmHg to \<170 mmHg, all of which are measured at Screening Visits. Data obtained will be used to confirm the effect of renal denervation on elevated blood pressure in patients on 1, 2 or 3 antihypertensive medications.

Conditions

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Hypertension Vascular Diseases Cardiovascular Diseases

Keywords

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Uncontrolled hypertension Renal denervation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Renal Denervation

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Group Type EXPERIMENTAL

Symplicity Spyral™ multi-electrode renal denervation system

Intervention Type DEVICE

After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Sham Procedure

Renal angiography

Group Type SHAM_COMPARATOR

Sham Procedure

Intervention Type PROCEDURE

After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Interventions

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Symplicity Spyral™ multi-electrode renal denervation system

After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Intervention Type DEVICE

Sham Procedure

After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Intervention Type PROCEDURE

Other Intervention Names

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Renal angiography Renal Denervation Renal angiography

Eligibility Criteria

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Inclusion Criteria

* Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and \<180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.
* Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and \< 170 mmHg.

Exclusion Criteria

* Individual lacks appropriate renal artery anatomy.
* Individual has estimated glomerular filtration rate (eGFR) of \<45.
* Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
* Individual has one or more episodes of orthostatic hypotension.
* Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
* Individual has primary pulmonary hypertension.
* Individual is pregnant, nursing or planning to become pregnant.
* Individual 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
* Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
* Individual works night shifts.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Vascular

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond Townsend, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

David Kandzari, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Hospital

Michael Böhm, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätskliniken des Saarlandes

Kazuomi Kario, MD

Role: PRINCIPAL_INVESTIGATOR

Jichi Medical University

Locations

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Heart Center Research, LLC

Huntsville, Alabama, United States

Site Status

Stanford Hospital and Clinics

Stanford, California, United States

Site Status

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Washington DC VA Medical Center

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

Site Status

Baptist Medical Center Jacksonville

Jacksonville, Florida, United States

Site Status

Memorial Hospital Jacksonville

Jacksonville, Florida, United States

Site Status

Tallahassee Research Institute

Tallahassee, Florida, United States

Site Status

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Piedmont Heart Institute

Atlanta, Georgia, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

St Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Providence Hospital

Southfield, Michigan, United States

Site Status

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Site Status

Cardiology Associates Research LLC

Tupelo, Mississippi, United States

Site Status

Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

Weill Cornell Medical College/The New York Presbyterian Hospital

New York, New York, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Oregon Health & Science University Hospital

Portland, Oregon, United States

Site Status

PinnacleHealth Cardiovascular Institute

Harrisburg, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

The Miriam Hospital

Providence, Rhode Island, United States

Site Status

AnMed Health

Anderson, South Carolina, United States

Site Status

Centennial Medical Center

Nashville, Tennessee, United States

Site Status

Baylor Heart & Vascular Hospital

Dallas, Texas, United States

Site Status

Charleston Area Medical Center

Charleston, West Virginia, United States

Site Status

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Alfred Hospital

Melbourne, Victoria, Australia

Site Status

St. George Hospital

Kogarah, , Australia

Site Status

Royal Perth

Perth, , Australia

Site Status

Klinikum Wels-Grieskirchen

Wels, , Austria

Site Status

Hamilton Heath

Hamilton, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH

Bad Krozingen, , Germany

Site Status

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status

Universitätsklinikum des Saarlandes

Homburg, , Germany

Site Status

Herzzentrum Leipzig, Universitätsklinik

Leipzig, , Germany

Site Status

Sana Kliniken Lübeck

Lübeck, , Germany

Site Status

Hippokration General Hospital of Athens

Athens, , Greece

Site Status

University General Hospital of Thessaloniki (AHEPA)

Thessaloniki, , Greece

Site Status

Galway University Hospital

Galway, , Ireland

Site Status

Higashi Takarazuka Satoh Hospital

Takarazuka, Hyōgo, Japan

Site Status

Shonan Kamakura General Hospital

Kamakura, Okamoto, Japan

Site Status

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Site Status

Mitsui Memorial Hospital

Chiyoda City, Tokyo, Japan

Site Status

Saiseikai Nakatsu Hospital

Osaka, , Japan

Site Status

Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Site Status

Cardiff and Vale University Health Board - University Hospital of Wales

Cardiff, , United Kingdom

Site Status

Royal Devon & Exeter NHS Foundation Trust

Exeter, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United States Australia Austria Canada France Germany Greece Ireland Japan United Kingdom

References

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Kandzari DE, Mahfoud F, Townsend RR, Kario K, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Liu M, DeBruin V, Brar S, Bohm M. Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial. Circ Cardiovasc Interv. 2025 Jul;18(7):e015194. doi: 10.1161/CIRCINTERVENTIONS.125.015194. Epub 2025 May 20.

Reference Type DERIVED
PMID: 40391448 (View on PubMed)

Townsend RR, Ferdinand KC, Kandzari DE, Kario K, Mahfoud F, Weber MA, Schmieder RE, Pocock S, Tsioufis K, David S, Steigerwalt S, Walton A, Hopper I, Bertolet B, Sharif F, Fengler K, Fahy M, Hettrick DA, Brar S, Bohm M. Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED. Hypertension. 2024 May;81(5):1095-1105. doi: 10.1161/HYPERTENSIONAHA.123.22251. Epub 2024 Feb 5.

Reference Type DERIVED
PMID: 38314554 (View on PubMed)

Kandzari DE, Townsend RR, Kario K, Mahfoud F, Weber MA, Schmieder RE, Pocock S, Tsioufis K, Konstantinidis D, Choi J, East C, Lauder L, Cohen DL, Kobayashi T, Schmid A, Lee DP, Ma A, Weil J, Agdirlioglu T, Schlaich MP, Shetty S, Devireddy CM, Lea J, Aoki J, Sharp ASP, Anderson R, Fahy M, DeBruin V, Brar S, Bohm M; SPYRAL HTN-ON MED Investigators. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. 2023 Nov 7;82(19):1809-1823. doi: 10.1016/j.jacc.2023.08.045.

Reference Type DERIVED
PMID: 37914510 (View on PubMed)

Mahfoud F, Kandzari DE, Kario K, Townsend RR, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Dimitriadis K, Choi JW, East C, D'Souza R, Sharp ASP, Ewen S, Walton A, Hopper I, Brar S, McKenna P, Fahy M, Bohm M. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. Lancet. 2022 Apr 9;399(10333):1401-1410. doi: 10.1016/S0140-6736(22)00455-X. Epub 2022 Apr 4.

Reference Type DERIVED
PMID: 35390320 (View on PubMed)

Kandzari DE, Hickey GL, Pocock SJ, Weber MA, Bohm M, Cohen SA, Fahy M, Lamberti G, Mahfoud F. Prioritised endpoints for device-based hypertension trials: the win ratio methodology. EuroIntervention. 2021 Apr 2;16(18):e1496-e1502. doi: 10.4244/EIJ-D-20-01090.

Reference Type DERIVED
PMID: 33226002 (View on PubMed)

Kario K, Weber MA, Bohm M, Townsend RR, Mahfoud F, Schmieder RE, Tsioufis K, Cohen SA, Fahy M, Kandzari DE. Effect of renal denervation in attenuating the stress of morning surge in blood pressure: post-hoc analysis from the SPYRAL HTN-ON MED trial. Clin Res Cardiol. 2021 May;110(5):725-731. doi: 10.1007/s00392-020-01718-6. Epub 2020 Aug 1.

Reference Type DERIVED
PMID: 32740754 (View on PubMed)

Bohm M, Townsend RR, Kario K, Kandzari D, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Hickey GL, Fahy M, DeBruin V, Brar S, Pocock S. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol. 2020 Mar;109(3):289-302. doi: 10.1007/s00392-020-01595-z. Epub 2020 Feb 7.

Reference Type DERIVED
PMID: 32034481 (View on PubMed)

Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.

Reference Type DERIVED
PMID: 29803589 (View on PubMed)

Kandzari DE, Kario K, Mahfoud F, Cohen SA, Pilcher G, Pocock S, Townsend R, Weber MA, Bohm M. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91. doi: 10.1016/j.ahj.2015.08.021. Epub 2015 Sep 11.

Reference Type DERIVED
PMID: 26699604 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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SPYRAL HTN-ON MED

Identifier Type: -

Identifier Source: org_study_id