Renal Denervation for Uncontrolled Hypertension

NCT02016573 | Withdrawn

• 2 other identifiers: 070/121034397
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study investigating the safety and usefulness of the Renal Denervation Procedure in reducing high blood pressure in people whose blood pressure is not adequately controlled despite already being treated with 2 blood pressure lowering drugs. This study is designed to compare the effects renal denervation to a usual care group.

Conditions

Hypertension

Keywords

renal denervation; blood pressure; cardiovascular risk; target organ damage; sympathetic activity

Outcome Measures

Primary Outcomes (1)

• blood pressure control

  percentage of patients who achieve BP target at 6 months post intervention

  6 months post procedure

Secondary Outcomes (9)

• number of drugs required to reach target blood pressure

  baseline to 6 months

• time to achieve blood pressure target

  baseline to 6 months

• change in sympathetic nerve activity

  baseline to 6 months

• Change in left ventricular function

  baseline to 6 months

• Change in Quality of Life

  baseline to 6 months

Study Arms (2)

Usual care

NO INTERVENTION

participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets

Renal Denervation Group

EXPERIMENTAL

participants randomised to undergo the renal denervation procedure

Device: Renal Denervation

Interventions

Renal Denervation DEVICE

Renal Denervation Catheter

Also known as: Symplicity Renal Denervation Catheter

Renal Denervation Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
• concurrent treatment with 2 anti-hypertensive drugs

You may not qualify if:

• renal artery anatomy ineligible for treatment
• eGFR \<15mL/min/1.73m2 (using MDRD formula)
• individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
• female participants of child bearing potential must have negative pregnancy test prior to treatment

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Markus P Schlaich, MD

  Baker IDI Heart & Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share