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OpenTrials
Completed

NCT Number: NCT00888433

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

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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Key information

Conditions

Uncontrolled Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alfred Hospital, Melbourne, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal Denervation (Symplicity® Renal Denervation System)

Device

Catheter-based renal denervation

Primary outcomes

  1. Office Systolic Blood Pressure Reduction

    Time frame: Baseline to 6 months

    The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Acronym: HTN-2

Important dates

Study start
2009
Primary completion
2010
Study completion
2015
First posted
Apr 27, 2009
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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