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An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental | Renal Denervation and maintenance of anti-hypertensive medications |
|
| Control | No Intervention | Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation (Symplicity® Renal Denervation System) | Device | Catheter-based renal denervation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Office Systolic Blood Pressure Reduction | The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murray Esler, MBBS | The Baker IDI Heart & Diabetes Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred Hospital | Melbourne | Australia | ||||
| Vienna General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21093036 | Result | Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17. | |
| 40813485 |
| Label | URL |
|---|---|
| Related Info | View source |
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84 subjects excluded pre-randomization due to blood pressure value at baseline visit (n=36); ineligible anatomy (n=30); declined participation (n=10); and other exclusion criteria (n=8).
190 patients screened as eligible for study inclusion between June 9, 2009 and January 15, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Denervation | Renal Denervation and maintenance of anti-hypertensive medications |
| FG001 | Control | Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vienna |
| Austria |
| Cliniques Universitaires Saint Luc | Brussels | Belgium |
| Hopital Européen Georges Pompidou | Paris | France |
| Herzzentrum Bad Krozingen | Bad Krozingen | Germany |
| Universität zu Köln | Cologne | Germany |
| Universitaetsklinikum Dusseldorf | Düsseldorf | Germany |
| University of Erlangen at Nuremburg | Erlangen | Germany |
| Universitaetsklinikum Essen | Essen | Germany |
| CardioVascular Center Frankfurt | Frankfurt | Germany |
| Universitatskliniken des Saarlandes | Homburg | Germany |
| University of Leipzig - Herzzentrum | Leipzig | Germany |
| Universitatsklinikum Schleswig-Holstein, Luebeck Campus | Leubeck | Germany |
| Pauls Stradins Clinical University Hospital | Riga | Latvia |
| Samodzielna Pracownia Hemodynamiczna | Warsaw | Poland |
| Hospital 12 de Octubre | Madrid | Spain |
| Universitaatsspital Zurich | Zurich | Switzerland |
| Kent and Canterbury Hospital | Canterbury | United Kingdom |
| University of Glasgow | Glasgow | United Kingdom |
| Barts and the London School of Dentistry & Medicine | London | United Kingdom |
| Xu J, Sesa-Ashton G, Eikelis N, Walton A, Lambert EA, Esler MD, Kiuchi MG, Carnagarin R, Lambert GW, Schlaich MP. Increased plasma levels of erythropoietin after renal denervation in patients with resistant hypertension. Hypertens Res. 2025 Oct;48(10):2631-2640. doi: 10.1038/s41440-025-02317-6. Epub 2025 Aug 14. |
| 28611687 | Derived | Eikelis N, Hering D, Marusic P, Duval J, Hammond LJ, Walton AS, Lambert EA, Esler MD, Lambert GW, Schlaich MP. The Effect of Renal Denervation on Plasma Adipokine Profile in Patients with Treatment Resistant Hypertension. Front Physiol. 2017 May 30;8:369. doi: 10.3389/fphys.2017.00369. eCollection 2017. |
| 26873693 | Derived | Schmieder RE, Ott C, Schmid A, Friedrich S, Kistner I, Ditting T, Veelken R, Uder M, Toennes SW. Adherence to Antihypertensive Medication in Treatment-Resistant Hypertension Undergoing Renal Denervation. J Am Heart Assoc. 2016 Feb 12;5(2):e002343. doi: 10.1161/JAHA.115.002343. |
| 24898552 | Derived | Esler MD, Bohm M, Sievert H, Rump CL, Schmieder RE, Krum H, Mahfoud F, Schlaich MP. Catheter-based renal denervation for treatment of patients with treatment-resistant hypertension: 36 month results from the SYMPLICITY HTN-2 randomized clinical trial. Eur Heart J. 2014 Jul;35(26):1752-9. doi: 10.1093/eurheartj/ehu209. Epub 2014 Jun 4. |
| 23780578 | Derived | Mahfoud F, Ukena C, Schmieder RE, Cremers B, Rump LC, Vonend O, Weil J, Schmidt M, Hoppe UC, Zeller T, Bauer A, Ott C, Blessing E, Sobotka PA, Krum H, Schlaich M, Esler M, Bohm M. Ambulatory blood pressure changes after renal sympathetic denervation in patients with resistant hypertension. Circulation. 2013 Jul 9;128(2):132-40. doi: 10.1161/CIRCULATIONAHA.112.000949. Epub 2013 Jun 18. |
| 23248063 | Derived | Esler MD, Krum H, Schlaich M, Schmieder RE, Bohm M, Sobotka PA; Symplicity HTN-2 Investigators. Renal sympathetic denervation for treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation. 2012 Dec 18;126(25):2976-82. doi: 10.1161/CIRCULATIONAHA.112.130880. |
| 21884958 | Derived | Ukena C, Mahfoud F, Kindermann I, Barth C, Lenski M, Kindermann M, Brandt MC, Hoppe UC, Krum H, Esler M, Sobotka PA, Bohm M. Cardiorespiratory response to exercise after renal sympathetic denervation in patients with resistant hypertension. J Am Coll Cardiol. 2011 Sep 6;58(11):1176-82. doi: 10.1016/j.jacc.2011.05.036. |
| 21518978 | Derived | Mahfoud F, Schlaich M, Kindermann I, Ukena C, Cremers B, Brandt MC, Hoppe UC, Vonend O, Rump LC, Sobotka PA, Krum H, Esler M, Bohm M. Effect of renal sympathetic denervation on glucose metabolism in patients with resistant hypertension: a pilot study. Circulation. 2011 May 10;123(18):1940-6. doi: 10.1161/CIRCULATIONAHA.110.991869. Epub 2011 Apr 25. |
| 21358414 | Derived | Schlaich MP, Straznicky N, Grima M, Ika-Sari C, Dawood T, Mahfoud F, Lambert E, Chopra R, Socratous F, Hennebry S, Eikelis N, Bohm M, Krum H, Lambert G, Esler MD, Sobotka PA. Renal denervation: a potential new treatment modality for polycystic ovary syndrome? J Hypertens. 2011 May;29(5):991-6. doi: 10.1097/HJH.0b013e328344db3a. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Renal Denervation | Renal Denervation and maintenance of anti-hypertensive medications |
| BG001 | Control | Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Office Systolic Blood Pressure Reduction | The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization. | Posted | Mean | Standard Deviation | mmHg | Baseline to 6 months |
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1. DENERVATION | Renal Denervation and maintenance of anti-hypertensive medications | 5 | 52 | 18 | 52 | ||
| EG001 | 2. CONTROL | Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months | 4 | 54 | 7 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Intra-Cerebral Aneurysm Operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertensive Crisis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertensive Crisis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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The institution agrees that no Publication of the Study Results may be made until Publication of the results of the multi-centre study or 2 years after Study Completion, whichever is sooner.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Murray Esler, Principal Investigator | Baker IDI Heart and Diabetes Institute | murray.esler@bakeridi.edu.au |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Poland |
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| Belgium |
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| Spain |
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| Australia |
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| Austria |
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| Latvia |
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| Germany |
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| Switzerland |
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| United Kingdom |
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