Renal Denervation for Resistant Hypertension

Phase 4

Terminated

• Conditions: Hypertension
• Interventions: Device: Renal Denervation

• Registration Number: NCT01865240
• Lead Sponsor: Baker Heart and Diabetes Institute

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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-05-27
• Study First Posted: 2013-05-30
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal Denervation Group	Renal Denervation	participants randomised to undergo the renal denervation procedure

Primary Outcome Measures

Name	Time	Method
blood pressure control	6 months post procedure	percentage of patients to achieve Blood Pressure (BP) target (BP \<140/90mmHg, or \<130/80mmHg in diabetic patients) at 6 months post procedure

Secondary Outcome Measures

Name	Time	Method
number of drugs required to reach blood pressure target	baseline to 6 months	number of drugs required to reach blood pressure target
Change in Left Ventricular Structure and Function	baseline to 6 months	Change in Left Ventricular mass index, ejection fraction, diastolic filling as assessed by echocardiogram
Change in Quality of Life	baseline to 6 months	Change in Quality of Life as assessed by relevant questionnaires
Serum and Urine Biochemistry	baseline to 6 months	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
Change in markers of arterial stiffness	baseline to 6 months	Change in markers of arterial stiffness including Augmentation Index (AI) and Pulse Wave Velocity (PWV)
time to achieve blood pressure target	baseline to 6 months	time to achieve blood pressure target
Change in markers of sympathetic nerve activity	baseline to 6 months	Changes in Muscle Sympathetic Nerve Activity (MSNA), renal and whole body Norepinephrine (NE) spillover

Trial Locations

Locations (1)

Baker IDI Heart & Diabetes Inst; 🇦🇺 Melbourne, Victoria, Australia