Renal Denervation for Resistant Hypertension (RDNP-2012-01)

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Device: Renal Denervation

Detailed Description

Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Baker IDI Heart & Diabetes Inst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal Denervation Group; participants randomised to undergo the renal denervation procedure	Device: Renal Denervation; Renal Denervation Catheter; Other Names: Symplicity Renal Denervation Catheter
No Intervention: Usual care; participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of drugs required to reach blood pressure target	number of drugs required to reach blood pressure target	baseline to 6 months
time to achieve blood pressure target	time to achieve blood pressure target	baseline to 6 months
Change in markers of sympathetic nerve activity	Changes in Muscle Sympathetic Nerve Activity (MSNA), renal and whole body Norepinephrine (NE) spillover	baseline to 6 months
Change in Left Ventricular Structure and Function	Change in Left Ventricular mass index, ejection fraction, diastolic filling as assessed by echocardiogram	baseline to 6 months
Change in Quality of Life	Change in Quality of Life as assessed by relevant questionnaires	baseline to 6 months
Serum and Urine Biochemistry	Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate (eGFR), urine albumin-to-creatinine ratio (UACR), inflammatory markers, 24hour urinary creatinine clearance, sodium, fasting glucose, fasting insulin, c-peptide, Homeostasis Model Assessment (HOMA) index, lipid profile	baseline to 6 months
Change in markers of arterial stiffness	Change in markers of arterial stiffness including Augmentation Index (AI) and Pulse Wave Velocity (PWV)	baseline to 6 months

Collaborators and Investigators

• Sponsor: Baker Heart and Diabetes Institute
• Investigators: Principal Investigator: Markus Schlaich, MD, Baker IDI Heart & Diabetes Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 27, 2013
• First Submitted That Met QC Criteria: May 27, 2013
• First Posted (Estimate): May 30, 2013

Study Record Updates

• Last Update Posted (Actual): November 5, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: cardiovascular risk; blood pressure; renal denervation; sympathetic activity; target organ damage
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 008/12; NHMRC (Other Grant/Funding Number: NRMRC)