Renal Denervation for Resistant Hypertension

NCT01865240 | Terminated Phase 4

• 2 other identifiers: 008/12NHMRC
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.

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 to achieve Blood Pressure (BP) target (BP \<140/90mmHg, or \<130/80mmHg in diabetic patients) at 6 months post procedure

  6 months post procedure

Secondary Outcomes (7)

• number of drugs required to reach blood pressure target

  baseline to 6 months

• time to achieve blood pressure target

  baseline to 6 months

• Change in markers of sympathetic nerve activity

  baseline to 6 months

• Change in Left Ventricular Structure and Function

  baseline to 6 months

• Change in Quality of Life

  baseline to 6 months

Study Arms (2)

Renal Denervation Group

EXPERIMENTAL

participants randomised to undergo the renal denervation procedure

Device: Renal Denervation

Usual care

NO INTERVENTION

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

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:

• systolic BP ≥140mmHg or ≥130mmHg for patients with diabetes
• concurrent treatment with ≥3 anti-hypertensive drugs

You may not qualify if:

• renal artery anatomy ineligible for treatment
• eGFR \<15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)
• female participants of childbearing potential must have negative pregnancy test prior to treatment

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead

Study Sites (1)

Baker IDI Heart & Diabetes Inst

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Markus Schlaich, MD

  Baker IDI Heart & Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: May 30, 2013
• Study Start: February 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 5, 2018

Record last verified: 2018-11

Locations

AU (1)