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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sunnybrook Health Sciences Centre
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: June 26, 2014
Last verified: June 2014
  Purpose

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 Intervention
Treatment-Resistant Hypertension
Device: Renal denervation device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pragmatic Randomized Clinical Evaluation of Renal Denervation for Treatment Resistant Hypertension

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Average systolic 24-hour ambulatory blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 104
Study Start Date: October 2013
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895140

Contacts
Contact: Harindra C. Wijeysundera, MD 416-480-4527 harindra.wijeysundera@sunnybrook.ca
Contact: Stephanie De Masi 416-864-6060 ext 7885 demasis@smh.ca

Locations
Canada, Ontario
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Harindra C. Wijeysundera, MD         
Principal Investigator: Eric Cohen, MD         
Principal Investigator: Harindra Wijeysundera, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: John J Graham, MD         
Principal Investigator: John J Graham, MD         
Principal Investigator: Abdul Al-Hesayen, MD         
Sponsors and Collaborators
Dr. Harindra Wijeysundera
Medtronic
MaRS Excellence in Clinical Innovation and Technology Evaluation (EXCITE)
Investigators
Principal Investigator: Harindra C. Wijeysundera, MD Sunnybrook Research Institute
  More Information

No publications provided

Responsible Party: Dr. Harindra Wijeysundera, Interventional Cardiologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01895140     History of Changes
Other Study ID Numbers: 322-2012
Study First Received: June 26, 2013
Last Updated: June 26, 2014
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Treatment-resistant hypertension
Renal denervation
Ambulatory blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014