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Prairie Renal Denervation Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Regina Qu'Appelle Health Region
Sponsor:
Information provided by (Responsible Party):
Regina Qu'Appelle Health Region
ClinicalTrials.gov Identifier:
NCT01832233
First received: March 27, 2013
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

People with hypertension are at a higher risk for cardiovascular disease and death so it is important to lower blood pressure to normal levels as quickly as possible. Previous research has established that renal nerve denervation successfully lowers blood pressure measured in the arm in the physician's office. This study is being conducted so that the investigators can determine whether renal nerve denervation also helps to lower blood pressure over 24 hours, as well as central aortic blood pressure, which is pressure exerted by the aorta closer to the heart and may be a better predictor of cardiovascular problems. The investigators also want to know whether these beneficial effects on blood pressure can last up to 2 years, whether renal denervation reduces the number of medications patients need to take, and whether it reduces glucose and insulin levels in the blood since hypertension is also related to obesity and diabetes.


Condition Intervention
Chronic Kidney Disease
Procedure: Symplicity Renal Denervation System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prairie Renal Denervation Study

Resource links provided by NLM:


Further study details as provided by Regina Qu'Appelle Health Region:

Primary Outcome Measures:
  • Change from Baseline in Peripheral Blood Pressure at 3 months Post-Renal Denervation [ Time Frame: Baseline to 3 months after treatment ] [ Designated as safety issue: No ]
    systolic and diastolic blood pressure (mm Hg) measured using BP-Tru machine.

  • Change from Baseline in Peripheral Blood Pressure at 6 months Post-Renal Denervation [ Time Frame: Baseline to 6 months after treatment ] [ Designated as safety issue: No ]
    systolic and diastolic blood pressure (mm Hg) measured using BP-Tru machine.

  • Change from Baseline in Peripheral Blood Pressure at 12-months Post-Renal Denervation [ Time Frame: Baseline to 12 months after treatment ] [ Designated as safety issue: No ]
    systolic and diastolic blood pressure (mm Hg) measured using BP-Tru machine.

  • Change from Baseline in Peripheral Blood Pressure at 18-months Post-Renal Denervation [ Time Frame: Baseline to 18 months after treatment ] [ Designated as safety issue: No ]
    systolic and diastolic blood pressure (mm Hg) measured using BP-Tru machine

  • Change from Baseline in Peripheral Blood Pressure at 24-months Post-Renal Denervation [ Time Frame: Baseline to 24 months after treatment ] [ Designated as safety issue: No ]
    systolic and diastolic blood pressure (mm Hg) measured using BP-Tru machine

  • Change from Baseline in Central Blood Pressure at 3-months Post-Renal Denervation [ Time Frame: Baseline to 3 months after treatment ] [ Designated as safety issue: No ]
    measured using ATCOR machine: Augmentation index (%) Augmentation pressure (mm Hg) Central pulse pressure (mm Hg) Central systolic pressure (mm Hg) Central diastolic pressure (mm Hg) Pulse pressure amplification (mm Hg) Time to reflection (Tr) in ms Pulse Wave Velocity

  • Change from Baseline in Central Blood Pressure at 6-months Post-Renal Denervation [ Time Frame: Baseline to 6 months after treatment ] [ Designated as safety issue: No ]
    measured using ATCOR machine: Augmentation index (%) Augmentation pressure (mm Hg) Central pulse pressure (mm Hg) Central systolic pressure (mm Hg) Central diastolic pressure (mm Hg) Pulse pressure amplification (mm Hg) Time to reflection (Tr) in ms Pulse Wave Velocity

  • Change from Baseline in Central Blood Pressure at 12-months Post-Renal Denervation [ Time Frame: Baseline to 12 months after treatment ] [ Designated as safety issue: No ]
    measured using ATCOR machine: Augmentation index (%) Augmentation pressure (mm Hg) Central pulse pressure (mm Hg) Central systolic pressure (mm Hg) Central diastolic pressure (mm Hg) Pulse pressure amplification (mm Hg) Time to reflection (Tr) in ms Pulse Wave Velocity

  • Change from Baseline in Central Blood Pressure at 18-months Post-Renal Denervation [ Time Frame: Baseline to 18 months after treatment ] [ Designated as safety issue: No ]
    measured using ATCOR machine: Augmentation index (%) Augmentation pressure (mm Hg) Central pulse pressure (mm Hg) Central systolic pressure (mm Hg) Central diastolic pressure (mm Hg) Pulse pressure amplification (mm Hg) Time to reflection (Tr) in ms Pulse Wave Velocity

  • Change from Baseline in Central Blood Pressure at 24-months Post-Renal Denervation [ Time Frame: Baseline to 24 months after treatment ] [ Designated as safety issue: No ]
    measured using ATCOR machine: Augmentation index (%) Augmentation pressure (mm Hg) Central pulse pressure (mm Hg) Central systolic pressure (mm Hg) Central diastolic pressure (mm Hg) Pulse pressure amplification (mm Hg) Time to reflection (Tr) in ms Pulse Wave Velocity

  • Change from Baseline in 24-Hour Ambulatory Blood Pressure at 3-months Post-Renal Denervation [ Time Frame: Baseline to 3 months after treatment ] [ Designated as safety issue: No ]

    For 24-hour blood pressure, we will record the following:

    12-hour daytime Systolic Pressure (mm Hg) 12-hour daytime Diastolic Pressure (mm Hg) 12-hour nighttime Systolic Pressure (mm Hg) 12-hour nighttime Diastolic Pressure (mm Hg)


  • Change from Baseline in 24-Hour Ambulatory Blood Pressure at 6-months Post-Renal Denervation [ Time Frame: Baseline to 6 months after treatment ] [ Designated as safety issue: No ]

    For 24-hour blood pressure, we will record the following:

    12-hour daytime Systolic Pressure (mm Hg) 12-hour daytime Diastolic Pressure (mm Hg) 12-hour nighttime Systolic Pressure (mm Hg) 12-hour nighttime Diastolic Pressure (mm Hg)


  • Change from Baseline in 24-Hour Ambulatory Blood Pressure at 12-months Post-Renal Denervation [ Time Frame: Baseline to 12 months after treatment ] [ Designated as safety issue: No ]

    For 24-hour blood pressure, we will record the following:

    12-hour daytime Systolic Pressure (mm Hg) 12-hour daytime Diastolic Pressure (mm Hg) 12-hour nighttime Systolic Pressure (mm Hg) 12-hour nighttime Diastolic Pressure (mm Hg)


  • Change from Baseline in 24-Hour Ambulatory Blood Pressure at 18-months Post-Renal Denervation [ Time Frame: Baseline to 18 months after treatment ] [ Designated as safety issue: No ]

    For 24-hour blood pressure, we will record the following:

    12-hour daytime Systolic Pressure (mm Hg) 12-hour daytime Diastolic Pressure (mm Hg) 12-hour nighttime Systolic Pressure (mm Hg) 12-hour nighttime Diastolic Pressure (mm Hg)


  • Change from Baseline in 24-Hour Ambulatory Blood Pressure at 24-months Post-Renal Denervation [ Time Frame: Baseline to 24 months after treatment ] [ Designated as safety issue: No ]

    For 24-hour blood pressure, we will record the following:

    12-hour daytime Systolic Pressure (mm Hg) 12-hour daytime Diastolic Pressure (mm Hg) 12-hour nighttime Systolic Pressure (mm Hg) 12-hour nighttime Diastolic Pressure (mm Hg)



Secondary Outcome Measures:
  • Change from Baseline in fasting glucose [ Time Frame: Baseline, Post 3, 6, 12, 18, 24 months after renal denervation treatment ] [ Designated as safety issue: No ]
    fasting blood measures of glucose

  • Change from Baseline in Cardiac Parameters [ Time Frame: Baseline, Post 12 and 24 months renal denervation treatment ] [ Designated as safety issue: No ]

    Using an echocardiogram, the following cardiac measures will be taken:

    Left ventricle volume Left ventricle hypertrophy Left ventricle function Left atrial mass E-wave velocity E-prime velocity


  • Change from Baseline in fasting insulin [ Time Frame: Baseline, Post 3, 6, 12, 18, 24 months after renal denervation treatment. ] [ Designated as safety issue: No ]
    fasting blood measure of insulin


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Denervation
Patients with resistant hypertension and chronic kidney disease (GFR between 15 and 60) will receive renal denervation as a treatment
Procedure: Symplicity Renal Denervation System
Symplicity Renal Denervation System consists of two main components: the Symplicity Catheter; and the Symplicity Radio Frequency Generator.The Symplicity Renal Denervation System is indicated for the delivery of low-level radiofrequency energy through the wall of the renal artery to denervate the kidney and reduce blood pressure in adult patients with refractory hypertension. The Symplicity Generator delivers controlled relatively low power radiofrequency energy (approximately 8 watts for 2 minutes). The Symplicity System selectively denervates the kidney by delivering radiofrequency from the generator via the electrode of the catheter through the renal artery wall from the intra-luminal side to ablate the renal sympathetic efferent and afferent nerves and reduce overall sympathetic nervous system activity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Glomerular filtration rate: 60-15 mls/min as per the modified diet in renal disease formula (Stage 3 and 4 Chronic Kidney Disease)
  • Daytime systolic blood pressure on ambulatory monitor ≥ 135 mm Hg while taking 3 or more anti-hypertensives including a diuretic on maximal dose OR ambulatory monitor systolic blood pressure is <135 but taking 4 or more anti-hypertensives
  • 18 years and above
  • A minimum of 20 mm of length and 4 mm of diameter for renal arteries on CT renal angiogram or formal renal angiogram

Exclusion Criteria:

  • not suitable for renal denervation based on the Indications for Use
  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: NCT01832233

Contacts
Contact: Bhanu Prasad 306-352-3018

Locations
Canada, Saskatchewan
Regina Qu'Appelle Health Region Recruiting
Regina, Saskatchewan, Canada
Contact: Bhanu Prasad         
Sponsors and Collaborators
Regina Qu'Appelle Health Region
  More Information

No publications provided

Responsible Party: Regina Qu'Appelle Health Region
ClinicalTrials.gov Identifier: NCT01832233     History of Changes
Other Study ID Numbers: REB12-73
Study First Received: March 27, 2013
Last Updated: April 11, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on November 24, 2014