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

Uncontrolled Hypertension Clinical Trial

— HTN-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888433
• Other study ID #: TP-058
• Status: Completed
• Phase: N/A
• First received: April 24, 2009
• Last updated: May 4, 2015
• Start date: June 2009
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 2015
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);

• on 3 or more antihypertensive medications

• >= 18 and =< 85 years of age.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

Device:
• Renal Denervation (Symplicity® Renal Denervation System)
Catheter-based renal denervation

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne
Austria	Vienna General Hospital	Vienna
Belgium	Cliniques Universitaires Saint Luc	Brussels
France	Hopital Européen Georges Pompidou	Paris
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Universität zu Köln	Cologne
Germany	Universitaetsklinikum Dusseldorf	Dusseldorf
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
Latvia	Pauls Stradins Clinical University Hospital	Riga
Poland	Samodzielna Pracownia Hemodynamiczna	Warsaw
Spain	Hospital 12 de Octubre	Madrid
Switzerland	Universitaatsspital Zurich	Zurich
United Kingdom	Kent and Canterbury Hospital	Canterbury
United Kingdom	University of Glasgow	Glasgow
United Kingdom	Barts and the London School of Dentistry & Medicine	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  France,  Germany,  Latvia,  Poland,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

Symplicity HTN-2 Investigators, Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Böhm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to 6 months	No

External Links

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