Status:
TERMINATED
A Study of Renal Denervation in Patients With Treatment Resistant Hypertension
Lead Sponsor:
Dr. Harindra Wijeysundera
Collaborating Sponsors:
Medtronic
Mars Excellence in Clinical Innovation and Technology Evaluation
Conditions:
Treatment-Resistant Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
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, C...
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 technolog...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01895140
Start Date
October 1 2013
End Date
October 1 2014
Last Update
October 13 2014
Active Locations (2)
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1
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8