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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

March 27, 2013
April 11, 2013
January 2013
January 2018   (final data collection date for primary outcome measure)
  • 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)

Same as current
Complete list of historical versions of study NCT01832233 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Prairie Renal Denervation Study
Prairie Renal Denervation Study

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Kidney Disease
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.
Experimental: Renal Denervation
Patients with resistant hypertension and chronic kidney disease (GFR between 15 and 60) will receive renal denervation as a treatment
Intervention: Procedure: Symplicity Renal Denervation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2018
January 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bhanu Prasad 306-352-3018
Canada
 
NCT01832233
REB12-73
No
Regina Qu'Appelle Health Region
Regina Qu'Appelle Health Region
Not Provided
Not Provided
Regina Qu'Appelle Health Region
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP