Clinical trial NCT01895140: A Study of Renal Denervation in Patients With Treatment Resistant Hypertension
Official title: A Pragmatic Randomized Clinical Evaluation of Renal Denervation for Treatment Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Treatment-Resistant Hypertension
Keywords: Treatment-resistant hypertension
Renal denervation
Ambulatory blood pressure
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Mars Excellence in Clinical Innovation and Technology Evaluation
First posted: 2013-07-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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%)

Exclusion Criteria:

* Secondary causes of hypertension:

  1. Primary aldosteronism (secondary to adrenal adenoma)
  2. Chronic kidney disease: creatinine clearance or eGFR \< 45 ml/min/1.73m² (measured on 24 hour urine preferably or MDRD)
  3. Pheochromocytoma
  4. Cushing's syndrome
  5. Aortic coarctation (differential in brachial or femoral pulses, systolic bruit)
* Type 1 diabetes mellitus
* Pregnancy

Primary outcomes:
measure: Average systolic 24-hour ambulatory blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: Average daytime and average night-time systolic ambulatory blood pressure
timeFrame: 6 months
measure: Variability of 24-hour ambulatory systolic blood pressure
timeFrame: 6 months
measure: Average office blood pressure using an approved, automated office blood pressure device
timeFrame: 6 months
measure: Hypertensive medication complexity index (MRCI)
timeFrame: 6 months
measure: Number of hypertensive medications
timeFrame: 6 months
measure: Peri-procedural mean cost per patient in Canadian dollars
timeFrame: 12 months
measure: Generic quality of life (EQ-5D)
timeFrame: 6 months
measure: Body Mass Index (BMI)
timeFrame: 6 months
measure: 24-hour urine sodium
timeFrame: 6 months
measure: Acute periprocedural renal injury
timeFrame: 72 hours post procedure
measure: Creatinine clearance measured on 24-hour urine (% change from baseline & indexed to Body Surface Area)
timeFrame: 6 months
measure: Vascular complications (dissection, pseudoaneurysm, AV fistula)
timeFrame: 6 months
measure: Evidence of renal artery stenosis compared to pre-procedure (determined by renal imaging, CT or MRA) for early intervention group
timeFrame: 6 months
measure: Composite cardiovascular endpoints (fatal & non-fatal MI, new onset heart failure, stroke, beginning dialysis, hospitalization for cardiovascular/renal reasons, increase in hypertension medications)
timeFrame: 6 months
measure: Microalbumin to creatinine ratio (MACR) from random urine sample (% change from baseline)
timeFrame: 6 months
measure: 24-hour urine sodium (% change from baseline)
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: Harindra C. Wijeysundera, MD
role: PRINCIPAL_INVESTIGATOR
References: