NCT01895140

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

June 26, 2013

Last Update Submit

October 10, 2014

Conditions

Treatment-Resistant Hypertension

Keywords

Treatment-resistant hypertensionRenal denervationAmbulatory blood pressure

Outcome Measures

Primary Outcomes (1)

  • Average systolic 24-hour ambulatory blood pressure

    6 months

Secondary Outcomes (17)

  • 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

  • Average daytime and average night-time systolic ambulatory blood pressure

    6 months

  • Variability of 24-hour ambulatory systolic blood pressure

    6 months

  • Average office blood pressure using an approved, automated office blood pressure device

    6 months

  • Hypertensive medication complexity index (MRCI)

    6 months

  • +12 more secondary outcomes

Study Arms (2)

Early renal denervation

EXPERIMENTAL

Renal denervation takes place immediately after patient is randomized.

Device: Renal denervation device

Delayed renal denervation

OTHER

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

Device: Renal denervation device

Interventions

Renal denervation deviceDEVICE
Also known as: Medtronic Symplicity™ Catheter Device
Delayed renal denervationEarly renal denervation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Study Officials

  • Harindra C. Wijeysundera, MD

    Sunnybrook Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 10, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 13, 2014

Record last verified: 2014-10

Locations

CA(2)