Brief Summary

An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

106

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach

9 countries

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.9 years study duration

First Submitted

Initial submission to the registry

April 24, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed

1 month until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed

3.5 years until next milestone

Results Posted

Study results publicly available

February 24, 2014

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed

Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

April 24, 2009

Results QC Date

September 13, 2013

Last Update Submit

May 4, 2015

Conditions

Uncontrolled Hypertension

Keywords

hypertensionrenal denervationsympathetic nervous systemRDN

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

Renal Denervation

EXPERIMENTAL

Renal Denervation and maintenance of anti-hypertensive medications

Device: Renal Denervation (Symplicity® Renal Denervation System)

Control

NO INTERVENTION

Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months

Interventions

Renal Denervation (Symplicity® Renal Denervation System)DEVICE

Catheter-based renal denervation

Renal Denervation

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

systolic blood pressure \>=160mmHg (\>=150 mmHg for type 2 diabetics);
on 3 or more antihypertensive medications
\>= 18 and =\< 85 years of age.

You may not qualify if:

renal artery abnormalities
eGFR \< 45mL/min
MI, angina, CVA within 6 months
Type 1 diabetes
ICD or pacemaker, or any other metallic implant not compatible with MRI
others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Medtronic Vascularlead

Study Sites (20)

Alfred Hospital

Melbourne, Australia

Location

Vienna General Hospital

Vienna, Austria

Location

Cliniques Universitaires Saint Luc

Brussels, Belgium

Location

Hopital Européen Georges Pompidou

Paris, France

Location

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

Universität zu Köln

Cologne, Germany

Location

Universitaetsklinikum Dusseldorf

Düsseldorf, Germany

Location

University of Erlangen at Nuremburg

Erlangen, Germany

Location

Universitaetsklinikum Essen

Essen, Germany

Location

CardioVascular Center Frankfurt

Frankfurt, Germany

Location

Universitatskliniken des Saarlandes

Homburg, Germany

Location

University of Leipzig - Herzzentrum

Leipzig, Germany

Location

Universitatsklinikum Schleswig-Holstein, Luebeck Campus

Leubeck, Germany

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Samodzielna Pracownia Hemodynamiczna

Warsaw, Poland

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Universitaatsspital Zurich

Zurich, Switzerland

Location

Kent and Canterbury Hospital

Canterbury, United Kingdom

Location

University of Glasgow

Glasgow, United Kingdom

Location

Barts and the London School of Dentistry & Medicine

London, United Kingdom

Location

Related Publications (9)

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.
PMID: 21093036RESULT
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.
PMID: 28611687DERIVED
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.
PMID: 26873693DERIVED
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.
PMID: 24898552DERIVED
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.
PMID: 23780578DERIVED
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.
PMID: 23248063DERIVED
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.
PMID: 21884958DERIVED
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.
PMID: 21518978DERIVED
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.
PMID: 21358414DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title: Murray Esler, Principal Investigator
Organization: Baker IDI Heart and Diabetes Institute

Study Officials

Murray Esler, MBBS
The Baker IDI Heart & Diabetes Institute
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2010

Study Completion

May 1, 2015

Last Updated

May 20, 2015

Results First Posted

February 24, 2014

Record last verified: 2015-05

Locations

AU(1)BE(1)FR(1)DE(9)LA(1)ES(1)GB(3)CH(1)PL(1)

Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Renal Denervation

Control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (20)

Related Publications (9)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Renal Denervation

Control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (20)

Related Publications (9)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations