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A Study of Renal Denervation in Patients With Treatment Resistant Hypertension (PaCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01895140
Recruitment Status : Terminated (Manufacturer updated device technology.)
First Posted : July 10, 2013
Last Update Posted : October 13, 2014
Mars Excellence in Clinical Innovation and Technology Evaluation
Information provided by (Responsible Party):
Dr. Harindra Wijeysundera, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Treatment-Resistant Hypertension Device: Renal denervation device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pragmatic Randomized Clinical Evaluation of Renal Denervation for Treatment Resistant Hypertension
Study Start Date : October 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Early renal denervation
Renal denervation takes place immediately after patient is randomized.
Device: Renal denervation device
Other Name: Medtronic Symplicity™ Catheter Device

Delayed renal denervation
Renal denervation takes place 6 months after the patient is randomized.
Device: Renal denervation device
Other Name: Medtronic Symplicity™ Catheter Device

Primary Outcome Measures :
  1. Average systolic 24-hour ambulatory blood pressure [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Average daytime and average night-time systolic ambulatory blood pressure [ Time Frame: 6 months ]
  3. Variability of 24-hour ambulatory systolic blood pressure [ Time Frame: 6 months ]
  4. Average office blood pressure using an approved, automated office blood pressure device [ Time Frame: 6 months ]
  5. Hypertensive medication complexity index (MRCI) [ Time Frame: 6 months ]
  6. Number of hypertensive medications [ Time Frame: 6 months ]
  7. Peri-procedural mean cost per patient in Canadian dollars [ Time Frame: 12 months ]
  8. Generic quality of life (EQ-5D) [ Time Frame: 6 months ]
  9. Body Mass Index (BMI) [ Time Frame: 6 months ]
  10. 24-hour urine sodium [ Time Frame: 6 months ]
  11. Acute periprocedural renal injury [ Time Frame: 72 hours post procedure ]
  12. Creatinine clearance measured on 24-hour urine (% change from baseline & indexed to Body Surface Area) [ Time Frame: 6 months ]
  13. Vascular complications (dissection, pseudoaneurysm, AV fistula) [ Time Frame: 6 months ]
  14. Evidence of renal artery stenosis compared to pre-procedure (determined by renal imaging, CT or MRA) for early intervention group [ Time Frame: 6 months ]
  15. 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 ]
  16. Microalbumin to creatinine ratio (MACR) from random urine sample (% change from baseline) [ Time Frame: 6 months ]
  17. 24-hour urine sodium (% change from baseline) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01895140

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Canada, Ontario
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Dr. Harindra Wijeysundera
Mars Excellence in Clinical Innovation and Technology Evaluation
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Principal Investigator: Harindra C. Wijeysundera, MD Sunnybrook Research Institute
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Responsible Party: Dr. Harindra Wijeysundera, Interventional Cardiologist, Sunnybrook Health Sciences Centre Identifier: NCT01895140    
Other Study ID Numbers: 322-2012
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Keywords provided by Dr. Harindra Wijeysundera, Sunnybrook Health Sciences Centre:
Treatment-resistant hypertension
Renal denervation
Ambulatory blood pressure
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases