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

Primary Purpose

Treatment-Resistant Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Renal denervation device
Sponsored by
Dr. Harindra Wijeysundera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment-Resistant Hypertension focused on measuring Treatment-resistant hypertension, Renal denervation, Ambulatory blood pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Research Institute
  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Early renal denervation

Delayed renal denervation

Arm Description

Renal denervation takes place immediately after patient is randomized.

Renal denervation takes place 6 months after the patient is randomized.

Outcomes

Primary Outcome Measures

Average systolic 24-hour ambulatory blood pressure

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
Average daytime and average night-time systolic ambulatory blood pressure
Variability of 24-hour ambulatory systolic blood pressure
Average office blood pressure using an approved, automated office blood pressure device
Hypertensive medication complexity index (MRCI)
Number of hypertensive medications
Peri-procedural mean cost per patient in Canadian dollars
Generic quality of life (EQ-5D)
Body Mass Index (BMI)
24-hour urine sodium
Acute periprocedural renal injury
Creatinine clearance measured on 24-hour urine (% change from baseline & indexed to Body Surface Area)
Vascular complications (dissection, pseudoaneurysm, AV fistula)
Evidence of renal artery stenosis compared to pre-procedure (determined by renal imaging, CT or MRA) for early intervention group
Composite cardiovascular endpoints (fatal & non-fatal MI, new onset heart failure, stroke, beginning dialysis, hospitalization for cardiovascular/renal reasons, increase in hypertension medications)
Microalbumin to creatinine ratio (MACR) from random urine sample (% change from baseline)
24-hour urine sodium (% change from baseline)

Full Information

First Posted
June 26, 2013
Last Updated
October 10, 2014
Sponsor
Dr. Harindra Wijeysundera
Collaborators
Medtronic, Mars Excellence in Clinical Innovation and Technology Evaluation
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1. Study Identification

Unique Protocol Identification Number
NCT01895140
Brief Title
A Study of Renal Denervation in Patients With Treatment Resistant Hypertension
Acronym
PaCE
Official Title
A Pragmatic Randomized Clinical Evaluation of Renal Denervation for Treatment Resistant Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
Manufacturer updated device technology.
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Harindra Wijeysundera
Collaborators
Medtronic, Mars Excellence in Clinical Innovation and Technology Evaluation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment-Resistant Hypertension
Keywords
Treatment-resistant hypertension, Renal denervation, Ambulatory blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early renal denervation
Arm Type
Experimental
Arm Description
Renal denervation takes place immediately after patient is randomized.
Arm Title
Delayed renal denervation
Arm Type
Other
Arm Description
Renal denervation takes place 6 months after the patient is randomized.
Intervention Type
Device
Intervention Name(s)
Renal denervation device
Other Intervention Name(s)
Medtronic Symplicity™ Catheter Device
Primary Outcome Measure Information:
Title
Average systolic 24-hour ambulatory blood pressure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Title
Average daytime and average night-time systolic ambulatory blood pressure
Time Frame
6 months
Title
Variability of 24-hour ambulatory systolic blood pressure
Time Frame
6 months
Title
Average office blood pressure using an approved, automated office blood pressure device
Time Frame
6 months
Title
Hypertensive medication complexity index (MRCI)
Time Frame
6 months
Title
Number of hypertensive medications
Time Frame
6 months
Title
Peri-procedural mean cost per patient in Canadian dollars
Time Frame
12 months
Title
Generic quality of life (EQ-5D)
Time Frame
6 months
Title
Body Mass Index (BMI)
Time Frame
6 months
Title
24-hour urine sodium
Time Frame
6 months
Title
Acute periprocedural renal injury
Time Frame
72 hours post procedure
Title
Creatinine clearance measured on 24-hour urine (% change from baseline & indexed to Body Surface Area)
Time Frame
6 months
Title
Vascular complications (dissection, pseudoaneurysm, AV fistula)
Time Frame
6 months
Title
Evidence of renal artery stenosis compared to pre-procedure (determined by renal imaging, CT or MRA) for early intervention group
Time Frame
6 months
Title
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
Title
Microalbumin to creatinine ratio (MACR) from random urine sample (% change from baseline)
Time Frame
6 months
Title
24-hour urine sodium (% change from baseline)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harindra C. Wijeysundera, MD
Organizational Affiliation
Sunnybrook Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

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A Study of Renal Denervation in Patients With Treatment Resistant Hypertension

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