Renal Denervation for Uncontrolled Hypertension (RDNP-2012-02)

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.

Study Overview

• Status: Withdrawn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

Detailed Description

This is a phase 4 randomised control trial of renal denervation for the treatment of uncontrolled hypertension.

Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure.

A total of 100 participants with uncontrolled blood pressure, treated with two blood pressure lowering medications will be recruited into the study. Patients will be assigned to one of two groups. Participants in Group 1 will be assigned to undergo the renal denervation procedure. Participants in group 2 will undergo usual care, receiving additional antihypertensive medication in an attempt to reach blood pressure targets.

The duration of this study is 36 months.

• Study Type: Interventional
• Phase: Not Applicable

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:

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

Exclusion Criteria:

• 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

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 who achieve BP target at 6 months post intervention	6 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to achieve blood pressure target	time to achieve blood pressure target	baseline to 6 months
number of drugs required to reach target blood pressure	number of drugs required to reach target blood pressure	baseline to 6 months
change in sympathetic nerve activity	changes in muscle sympathetic nerve activity (MSNA), renal and whole body Noradrenaline (NA) spillover	baseline to 6 months
Change in left ventricular function	Change in left Ventricular ejection fraction, diastolic filling	baseline to 6 months
Change in Quality of Life	Change in Quality of life as assessed be relevant questionnaires	baseline to 6 months
Change in Serum Biochemistry	Plasma Renin Activity, aldosterone levels, estimated Glomerular Filtration Rate(eGFR), inflammatory markers, 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 as assessed by Augmentation Index (AI) and Pulse Wave Velocity (PWV)	baseline to 6 months
Change in left ventricular structure	Change in left ventricular mass index	baseline to 6 months
Change in Urine Biochemistry	Urinary albumin creatinine ratio (UACR), 24 hour urinary creatinine clearance, sodium	baseline to 6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2013
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: December 16, 2013
• First Posted (Estimate): December 20, 2013

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 4, 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: 070/12; 1034397 (Other Grant/Funding Number: NHMRC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data available