Hypertension
Conditions
Keywords
Renal denervation, Blood pressure, Cardiovascular risk, Target organ damage, Sympathetic activity, Non-compliance
Brief summary
The purpose of this study is to assess the efficacy of catheter-based renal denervation in reducing blood pressure in patients with resistant hypertension compared to a sham procedure. Patients will be randomized to RDN or sham control in a 2:1 ratio. All participants will be switched to a single pill triple combination treatment prior to the procedure. A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35 patients in the sham control arm. The duration of this study is 36 months.
Interventions
DEVICERenal Denervation
Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries.
OTHERSham control
Arterial access only. No delivery of radio frequency energy to renal arteries.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* systolic office BP ≥140mmHg and ambulatory day time average ≥135mmHg despite concurrent treatment with ≥3 anti-hypertensive drugs
Exclusion criteria
* renal artery anatomy ineligible for treatment * eGFR \<15mL/min/1.73m2 (using MDRD calculation) * myocardial infarction, unstable angina or cerebrovascular accident within 3 months of screening visit * life expectancy of \<12 months * female participants of childbearing potential must have negative pregnancy test prior to treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ambulatory systolic blood pressure between groups | 6 months post procedure | Difference in mean ambulatory systolic daytime blood pressure between RDN group and sham-control group at 6 month follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean 24h systolic blood pressure between groups | 6 months post procedure | Change in mean 24h systolic blood pressure between RDN group and sham-control group at 6 month follow up. |
| Change in mean night time systolic blood pressure between groups | 6 months post procedure | Change in mean night time systolic blood pressure between RDN group and sham-control group at 6 month follow up. |
| Change in mean office systolic blood pressure between groups | 6 months post procedure | Change in mean office systolic blood pressure between RDN group and sham-control group at 6 month follow up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular function between groups | 6 months post procedure | Change in left ventricular function (LV mass index, ejection fraction, diastolic filling) between groups |
| Change in Serum Biochemistry between groups | 6 months post procedure | 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 between groups |
| Change in Urine Biochemistry between groups | 6 months post procedure | Urinary albumin creatinine ratio (UACR), 24 hour urinary creatinine clearance, sodium between groups |
| Change in percentage of patients achieving BP target between groups | 6 months post procedure | Change in percentage of patients achieving BP target between groups |
| Change in cognitive function between groups | 6 months post procedure | Change in cognitive function as assessed by relevant questionnaires and assessment tools between groups |
| Change in microRNA expression between groups | 6 months post procedure | Change in microRNA expression as assessed by relevant assays between groups |
| Change in Quality of Life between groups | 6 months post procedure | Change in Quality of life as assessed by relevant questionnaires between groups |
| Change in percentage of patients with an ambulatory systolic BP reduction ≥5mmHg between groups | 6 months post procedure | Change in percentage of patients with an ambulatory systolic BP reduction ≥5mmHg between groups |
| Change in percentage of patients with an office systolic BP reduction ≥10mmHg between groups | 6 months post procedure | Change in percentage of patients with an office systolic BP reduction ≥10mmHg between groups |
| Change of sympathetic nerve activity between groups | 6 months post procedure | Change of sympathetic nerve activity (MSNA, renal and whole body NE spillover) between groups |
Countries
Australia
Outcome results
None listed