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

This study has been terminated.
(Manufacturer updated device technology.)
Sponsor:
Collaborators:
Medtronic
MaRS Excellence in Clinical Innovation and Technology Evaluation (EXCITE)
Information provided by (Responsible Party):
Dr. Harindra Wijeysundera, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01895140
First received: June 26, 2013
Last updated: October 10, 2014
Last verified: October 2014

June 26, 2013
October 10, 2014
October 2013
October 2014   (final data collection date for primary outcome measure)
Average systolic 24-hour ambulatory blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01895140 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Average daytime and average night-time systolic ambulatory blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Variability of 24-hour ambulatory systolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Average office blood pressure using an approved, automated office blood pressure device [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hypertensive medication complexity index (MRCI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of hypertensive medications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Peri-procedural mean cost per patient in Canadian dollars [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Generic quality of life (EQ-5D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body Mass Index (BMI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 24-hour urine sodium [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Acute periprocedural renal injury [ Time Frame: 72 hours post procedure ] [ Designated as safety issue: Yes ]
  • Creatinine clearance measured on 24-hour urine (% change from baseline & indexed to Body Surface Area) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Vascular complications (dissection, pseudoaneurysm, AV fistula) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Evidence of renal artery stenosis compared to pre-procedure (determined by renal imaging, CT or MRA) for early intervention group [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Microalbumin to creatinine ratio (MACR) from random urine sample (% change from baseline) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 24-hour urine sodium (% change from baseline) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Average daytime and average night-time systolic ambulatory blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Variability of 24-hour ambulatory systolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Average office blood pressure using an approved, automated office blood pressure device [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hypertensive medication complexity index (MRCI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of hypertensive medications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Peri-procedural mean cost per patient in Canadian dollars [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Generic quality of life (EQ-5D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body Mass Index (BMI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 24-hour urine sodium [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Acute periprocedural renal injury [ Time Frame: 72 hours post procedure ] [ Designated as safety issue: Yes ]
  • Creatinine clearance measured on 24-hour urine (% change from baseline & indexed to Body Surface Area) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Vascular complications (dissection, pseudoaneurysm, AV fistula) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Evidence of renal artery stenosis compared to pre-procedure (determined by renal imaging, CT or MRA) for early intervention group [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Microalbumin to creatinine ratio (MACR) from random urine sample (% change from baseline) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Microalbumin to creatinine ratio (MACR) from 24-hour urine sample (% change from baseline) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
  • Average systolic 24-hour ambulatory blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Average daytime ambulatory blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Average night-time ambulatory blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Variability of 24-hour ambulatory blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Average office blood pressure using an approved, automated office blood pressure device [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Hypertensive medication complexity index (MRCI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of hypertensive medications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Creatinine clearance measured on 24-hour urine (% change from baseline & indexed to Body Surface Area) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Evidence of renal artery stenosis compared to pre-procedure (determined by renal imaging, CT or MRA) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Composite cardiovascular endpoint (fatal & non-fatal MI, new onset heart failure, stroke, beginning dialysis, hospitalization for cardiovascular/renal reasons, increase in hypertension medications) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Microalbumin to creatinine ratio (MACR) from random urine sample (% change from baseline) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Microalbumin to creatinine ratio (MACR) from 24-hour urine sample (% change from baseline) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
 
A Study of Renal Denervation in Patients With Treatment Resistant Hypertension
A Pragmatic Randomized Clinical Evaluation of Renal Denervation for Treatment Resistant Hypertension

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Treatment-Resistant Hypertension
Device: Renal denervation device
Other Name: Medtronic Symplicity™ Catheter Device
  • Experimental: Early renal denervation
    Renal denervation takes place immediately after patient is randomized.
    Intervention: Device: Renal denervation device
  • Delayed renal denervation
    Renal denervation takes place 6 months after the patient is randomized.
    Intervention: Device: Renal denervation device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01895140
322-2012
Yes
Dr. Harindra Wijeysundera, Sunnybrook Health Sciences Centre
Dr. Harindra Wijeysundera
  • Medtronic
  • MaRS Excellence in Clinical Innovation and Technology Evaluation (EXCITE)
Principal Investigator: Harindra C. Wijeysundera, MD Sunnybrook Research Institute
Sunnybrook Health Sciences Centre
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP