A Study of Renal Denervation in Patients With Treatment Resistant Hypertension
- Conditions
- Treatment-Resistant Hypertension
- Interventions
- Device: Renal denervation device
- Registration Number
- NCT01895140
- Lead Sponsor
- Dr. Harindra Wijeysundera
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- Ontario residents
- Aged 18 and over
- Diagnosis of treatment-resistant hypertension after assessment and optimization by a hypertension specialist following recommended evaluation and diagnosis as outlined by the American Heart Association
- Office systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for patients with type II diabetes mellitus) prior to optimization by a hypertension specialist
- Baseline average systolic 24 hour ambulatory blood pressure of ≥ 135 mmHg after optimization and prior to randomization
- Prescribed 3 or more antihypertensive medications of different classes, both prior to optimization and at randomization, one of which must be a diuretic (a medication can be counted more than once if it acts on different receptors)
- Suitable renal artery anatomy based on CT/MRI/renal angiography imaging: both renal arteries > 20 mm in length and > 4 mm in diameter without significant fibromuscular disease or renal artery stenosis (>50%)
-
Secondary causes of hypertension:
- Primary aldosteronism (secondary to adrenal adenoma)
- Chronic kidney disease: creatinine clearance or eGFR < 45 ml/min/1.73m² (measured on 24 hour urine preferably or MDRD)
- Pheochromocytoma
- Cushing's syndrome
- Aortic coarctation (differential in brachial or femoral pulses, systolic bruit)
-
Type 1 diabetes mellitus
-
Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early renal denervation Renal denervation device Renal denervation takes place immediately after patient is randomized. Delayed renal denervation Renal denervation device Renal denervation takes place 6 months after the patient is randomized.
- Primary Outcome Measures
Name Time Method Average systolic 24-hour ambulatory blood pressure 6 months
- Secondary Outcome Measures
Name Time Method Average daytime and average night-time systolic ambulatory blood pressure 6 months Number of hypertensive medications 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) 6 months 24-hour urine sodium (% change from baseline) 6 months Average office blood pressure using an approved, automated office blood pressure device 6 months Peri-procedural mean cost per patient in Canadian dollars 12 months Hypertensive medication complexity index (MRCI) 6 months Body Mass Index (BMI) 6 months Vascular complications (dissection, pseudoaneurysm, AV fistula) 6 months Evidence of renal artery stenosis compared to pre-procedure (determined by renal imaging, CT or MRA) for early intervention group 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 6 months Variability of 24-hour ambulatory systolic blood pressure 6 months Generic quality of life (EQ-5D) 6 months 24-hour urine sodium 6 months Acute periprocedural renal injury 72 hours post procedure Creatinine clearance measured on 24-hour urine (% change from baseline & indexed to Body Surface Area) 6 months Microalbumin to creatinine ratio (MACR) from random urine sample (% change from baseline) 6 months
Trial Locations
- Locations (2)
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Research Institute
🇨🇦Toronto, Ontario, Canada