The purpose of this study is to evaluate the clinical and economic impact of implementation of renal denervation with the Symplicity™ Catheter System for treatment-resistant hypertension in Ontario, Canada.
This is a pragmatic randomized trial of renal nerve denervation for treatment resistant hypertension. This is part of a ministry sponsored MaRS-EXCITE program, to conduct early market health technology assessment, in order to determine appropriateness for provincial funding. We will assess the effectiveness, safety, economic attractiveness and feasibility of implementation of renal nerve denervation for treatment resistant hypertension. This will involve a new model of care which will include a multi-disciplinary team approach to these patients. Treatment resistant hypertension is defined as patients with uncontrolled hypertension despite being on optimal doses of 3 or more anti-hypertensive medications. Patients will be randomized to either standard treatment or renal nerve denervation and followed for 6 months to determine impact on blood pressure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Sunnybrook Research Institute
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Average systolic 24-hour ambulatory blood pressure
Time frame: 6 months
Proportion of patients achieving target systolic blood pressure (on average 24-hour ambulatory blood pressure of <130 mmHg) on the same or fewer medications at the time of randomization
Time frame: 6 months
Average daytime and average night-time systolic ambulatory blood pressure
Time frame: 6 months
Variability of 24-hour ambulatory systolic blood pressure
Time frame: 6 months
Average office blood pressure using an approved, automated office blood pressure device
Time frame: 6 months
Hypertensive medication complexity index (MRCI)
Time frame: 6 months
Number of hypertensive medications
Time frame: 6 months
Peri-procedural mean cost per patient in Canadian dollars
Time frame: 12 months
Generic quality of life (EQ-5D)
Time frame: 6 months
Body Mass Index (BMI)
Time frame: 6 months
24-hour urine sodium
Time frame: 6 months
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Acute periprocedural renal injury
Time frame: 72 hours post procedure
Creatinine clearance measured on 24-hour urine (% change from baseline & indexed to Body Surface Area)
Time frame: 6 months
Vascular complications (dissection, pseudoaneurysm, AV fistula)
Time frame: 6 months
Evidence of renal artery stenosis compared to pre-procedure (determined by renal imaging, CT or MRA) for early intervention group
Time frame: 6 months
Composite cardiovascular endpoints (fatal & non-fatal MI, new onset heart failure, stroke, beginning dialysis, hospitalization for cardiovascular/renal reasons, increase in hypertension medications)
Time frame: 6 months
Microalbumin to creatinine ratio (MACR) from random urine sample (% change from baseline)
Time frame: 6 months
24-hour urine sodium (% change from baseline)
Time frame: 6 months