Renal Denervation for Complicated Hypertension

Phase 4

Terminated

• Conditions: Hypertension
• Interventions: Device: Renal Denervation

• Registration Number: NCT01865253
• Lead Sponsor: Baker Heart and Diabetes Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-05-27
• Study First Posted: 2013-05-30
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Renal Denervation	Renal Denervation treatment

Primary Outcome Measures

Name	Time	Method
Change in average office blood pressure	baseline to 6 months post procedure	Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure

Secondary Outcome Measures

Name	Time	Method
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)
Change in Quality of life	baseline to 6 months post procedure	Change in Quality of life as assessed by relevant questionnaires
Blood pressure control	baseline to 6 months post procedure	Percentage of patients who achieved BP target at 6 months post procedure
Time to achieve blood pressure target	baseline to 6 months post procedure	Time to achieve blood pressure target
Change in sympathetic nerve activity	baseline to 6 months post procedure	Change in muscle sympathetic nerve activity, renal and whole body Noradrenaline (NA) spillover
Change in left ventricular structure and function	baseline to 6 months post procedure	Change in left Ventricular mass index, Ejection Fraction, diastolic filling
Number of drugs required to reach target blood pressure	baseline to 6 months post procedure	Number of drugs required to reach target blood pressure
Change in serum and urine Biochemistry	baseline to 6 months post procedure	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.

Trial Locations

Locations (1)

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