Hypertension
Conditions
Keywords
renal denervation, blood pressure, cardiovascular risk, target organ damage, sympathetic activity, chronic kidney disease, non-compliance
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.
Interventions
DEVICERenal Denervation
Renal Denervation
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of drugs required to reach target blood pressure | baseline to 6 months post procedure | Number of drugs required to reach target blood pressure |
| 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 |
| Blood pressure control | baseline to 6 months post procedure | Percentage of patients who achieved BP target at 6 months post procedure |
| Change in Quality of life | baseline to 6 months post procedure | Change in Quality of life as assessed by relevant questionnaires |
| 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. |
| 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 left ventricular structure and function | baseline to 6 months post procedure | Change in left Ventricular mass index, Ejection Fraction, diastolic filling |
Countries
Australia
Outcome results
None listed