Renal Denervation for Complicated Hypertension

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Device: Renal Denervation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Renal Denervation treatment | Device: Renal Denervation<br>* Renal Denervation<br>* Other names: Symplicity Renal Denervation Catheter;|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal denervation, blood pressure, cardiovascular risk, target organ damage, sympathetic activity, chronic kidney disease, non-compliance