A Study of Renal Denervation in Patients With Treatment Resistant Hypertension

Treatment-Resistant Hypertension Clinical Trial

— PaCE  

Official title:

A Pragmatic Randomized Clinical Evaluation of Renal Denervation for Treatment Resistant Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01895140
• Other study ID #: 322-2012
• Status: Terminated
• Phase: N/A
• First received: June 26, 2013
• Last updated: October 10, 2014
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Treatment-Resistant Hypertension

Intervention

Device:
• Renal denervation device

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Research Institute	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Harindra Wijeysundera	Mars Excellence in Clinical Innovation and Technology Evaluation, Medtronic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average systolic 24-hour ambulatory blood pressure		6 months	No
Secondary	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		6 months	No
Secondary	Average daytime and average night-time systolic ambulatory blood pressure		6 months	No
Secondary	Variability of 24-hour ambulatory systolic blood pressure		6 months	No
Secondary	Average office blood pressure using an approved, automated office blood pressure device		6 months	No
Secondary	Hypertensive medication complexity index (MRCI)		6 months	No
Secondary	Number of hypertensive medications		6 months	No
Secondary	Peri-procedural mean cost per patient in Canadian dollars		12 months	No
Secondary	Generic quality of life (EQ-5D)		6 months	No
Secondary	Body Mass Index (BMI)		6 months	No
Secondary	24-hour urine sodium		6 months	No
Secondary	Acute periprocedural renal injury		72 hours post procedure	Yes
Secondary	Creatinine clearance measured on 24-hour urine (% change from baseline & indexed to Body Surface Area)		6 months	Yes
Secondary	Vascular complications (dissection, pseudoaneurysm, AV fistula)		6 months	Yes
Secondary	Evidence of renal artery stenosis compared to pre-procedure (determined by renal imaging, CT or MRA) for early intervention group		6 months	Yes
Secondary	Composite cardiovascular endpoints (fatal & non-fatal MI, new onset heart failure, stroke, beginning dialysis, hospitalization for cardiovascular/renal reasons, increase in hypertension medications)		6 months	Yes
Secondary	Microalbumin to creatinine ratio (MACR) from random urine sample (% change from baseline)		6 months	Yes
Secondary	24-hour urine sodium (% change from baseline)		6 months	Yes