Hypertension
Conditions
Keywords
renal denervation, blood pressure, cardiovascular risk, target organ damage, sympathetic activity
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.
Interventions
DEVICERenal Denervation
Renal Denervation Catheter
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| number of drugs required to reach blood pressure target | baseline to 6 months | number of drugs required to reach blood pressure target |
| 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) |
| Change in Quality of Life | baseline to 6 months | Change in Quality of Life as assessed by relevant questionnaires |
Countries
Australia
Outcome results
None listed