Renal Denervation for Uncontrolled Hypertension

Not Applicable

Withdrawn

• Conditions: Hypertension
• Interventions: Device: Renal Denervation

• Registration Number: NCT02016573
• Lead Sponsor: Baker Heart and Diabetes Institute

Brief Summary

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.

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-20
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-04
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & 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 who achieve BP target at 6 months post intervention

Secondary Outcome Measures

Name	Time	Method
number of drugs required to reach target blood pressure	baseline to 6 months	number of drugs required to reach target blood pressure
Change in left ventricular function	baseline to 6 months	Change in left Ventricular ejection fraction, diastolic filling
Change in Quality of Life	baseline to 6 months	Change in Quality of life as assessed be relevant questionnaires
time to achieve blood pressure target	baseline to 6 months	time to achieve blood pressure target
Change in markers of arterial stiffness	baseline to 6 months	Change in markers of arterial stiffness as assessed by Augmentation Index (AI) and Pulse Wave Velocity (PWV)
Change in left ventricular structure	baseline to 6 months	Change in left ventricular mass index
Change in Urine Biochemistry	baseline to 6 months	Urinary albumin creatinine ratio (UACR), 24 hour urinary creatinine clearance, sodium
change in sympathetic nerve activity	baseline to 6 months	changes in muscle sympathetic nerve activity (MSNA), renal and whole body Noradrenaline (NA) spillover
Change in Serum Biochemistry	baseline to 6 months	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