Renal Denervation for Complicated Hypertension (RDNP-2012-03)

Renal Denervation for Complicated Hypertension (RDNP-2012-03)

This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to:

• intolerance to antihypertensive medication
• inability to take antihypertensive medication due to planned pregnancy
• renal artery stenosis
• chronic kidney disease
• non-compliance to antihypertensive medication

A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study.

The duration of this study is 36 months.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

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

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)
• Intolerance to ≥2 antihypertensive drug classes
• Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy
• Renal artery stenosis
• Chronic Kidney Disease

Exclusion Criteria:

• renal artery anatomy ineligible for treatment
• individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal Denervation; Renal Denervation treatment	Device: Renal Denervation; Renal Denervation; Other Names: Symplicity Renal Denervation Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average office blood pressure	Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure	baseline to 6 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood pressure control	Percentage of patients who achieved BP target at 6 months post procedure	baseline to 6 months post procedure
Number of drugs required to reach target blood pressure	Number of drugs required to reach target blood pressure	baseline to 6 months post procedure
Time to achieve blood pressure target	Time to achieve blood pressure target	baseline to 6 months post procedure
Change in sympathetic nerve activity	Change in muscle sympathetic nerve activity, renal and whole body Noradrenaline (NA) spillover	baseline to 6 months post procedure
Change in left ventricular structure and function	Change in left Ventricular mass index, Ejection Fraction, diastolic filling	baseline to 6 months post procedure
Change in Quality of life	Change in Quality of life as assessed by relevant questionnaires	baseline to 6 months post procedure
Change in serum and urine Biochemistry	Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate(eGFR), Urinary Albumin Creatinine Ratio (UACR), inflammatory markers, 24hour urine creatinine clearance, sodium, fasting glucose, fasting insulin, c peptide, Homeostasis Model Assessment (HOMA) index, lipid profile.	baseline to 6 months post procedure

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: May 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

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; chronic kidney disease; blood pressure; renal denervation; sympathetic activity; non-compliance; target organ damage
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 087/12; 1034397 (Other Grant/Funding Number: NHMRC)