A Study of Renal Denervation in Patients With Treatment Resistant Hypertension

NCT ID: NCT01895140

Last Updated: 2014-10-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-10-31

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.

Conditions

Treatment-Resistant Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early renal denervation

Renal denervation takes place immediately after patient is randomized.

Group Type: EXPERIMENTAL

Renal denervation device

Intervention Type: DEVICE

Delayed renal denervation

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

Group Type: OTHER

Renal denervation device

Intervention Type: DEVICE

Interventions

Renal denervation device

Intervention Type: DEVICE

Other Intervention Names

Medtronic Symplicity™ Catheter Device

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Mars Excellence in Clinical Innovation and Technology Evaluation

OTHER

Sponsor Role: collaborator

Dr. Harindra Wijeysundera

OTHER

Sponsor Role: lead

Responsible Party

Dr. Harindra Wijeysundera

Interventional Cardiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Harindra C. Wijeysundera, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Research Institute

Locations

Sunnybrook Research Institute

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

322-2012

Identifier Type: -

Identifier Source: org_study_id