Hypertension
Conditions
Keywords
renal denervation, blood pressure, cardiovascular risk, target organ damage, sympathetic activity
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.
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure control | 6 months post procedure | percentage of patients who achieve BP target at 6 months post intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to achieve blood pressure target | baseline to 6 months | time to achieve blood pressure target |
| 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 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 |
| number of drugs required to reach target blood pressure | baseline to 6 months | number of drugs required to reach target blood pressure |
| 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 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 |
Outcome results
None listed