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Renal Denervation for Complicated Hypertension (RDNP-2012-03)

Primary Purpose

Hypertension

Status
Terminated
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Renal Denervation
Sponsored by
Baker Heart and Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring renal denervation, blood pressure, cardiovascular risk, target organ damage, sympathetic activity, chronic kidney disease, non-compliance

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
  • Intolerance to ≥2 antihypertensive drug classes
  • Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy
  • Renal artery stenosis
  • Chronic Kidney Disease

Exclusion Criteria:

  • renal artery anatomy ineligible for treatment
  • individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
  • female participants of childbearing potential must have negative pregnancy test prior to treatment

Sites / Locations

  • Baker IDI Heart & Diabetes Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal Denervation

Arm Description

Renal Denervation treatment

Outcomes

Primary Outcome Measures

Change in average office blood pressure
Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure

Secondary Outcome Measures

Blood pressure control
Percentage of patients who achieved BP target at 6 months post procedure
Number of drugs required to reach target blood pressure
Number of drugs required to reach target blood pressure
Time to achieve blood pressure target
Time to achieve blood pressure target
Change in sympathetic nerve activity
Change in muscle sympathetic nerve activity, renal and whole body Noradrenaline (NA) spillover
Change in left ventricular structure and function
Change in left Ventricular mass index, Ejection Fraction, diastolic filling
Change in Quality of life
Change in Quality of life as assessed by relevant questionnaires
Change in serum and urine Biochemistry
Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate(eGFR), Urinary Albumin Creatinine Ratio (UACR), inflammatory markers, 24hour urine creatinine clearance, sodium, fasting glucose, fasting insulin, c peptide, Homeostasis Model Assessment (HOMA) index, lipid profile.
Change in markers of arterial stiffness
Change in markers of arterial stiffness including Augmentation Index (AI) and Pulse Wave Velocity (PWV)

Full Information

First Posted
May 27, 2013
Last Updated
November 1, 2018
Sponsor
Baker Heart and Diabetes Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01865253
Brief Title
Renal Denervation for Complicated Hypertension
Acronym
RDNP-2012-03
Official Title
Renal Denervation for Complicated Hypertension (RDNP-2012-03)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
No new participants enrolled. Protocol superseded.
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baker Heart and Diabetes Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to: intolerance to antihypertensive medication inability to take antihypertensive medication due to planned pregnancy renal artery stenosis chronic kidney disease non-compliance to antihypertensive medication A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study. The duration of this study is 36 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
renal denervation, blood pressure, cardiovascular risk, target organ damage, sympathetic activity, chronic kidney disease, non-compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation
Arm Type
Experimental
Arm Description
Renal Denervation treatment
Intervention Type
Device
Intervention Name(s)
Renal Denervation
Other Intervention Name(s)
Symplicity Renal Denervation Catheter
Intervention Description
Renal Denervation
Primary Outcome Measure Information:
Title
Change in average office blood pressure
Description
Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure
Time Frame
baseline to 6 months post procedure
Secondary Outcome Measure Information:
Title
Blood pressure control
Description
Percentage of patients who achieved BP target at 6 months post procedure
Time Frame
baseline to 6 months post procedure
Title
Number of drugs required to reach target blood pressure
Description
Number of drugs required to reach target blood pressure
Time Frame
baseline to 6 months post procedure
Title
Time to achieve blood pressure target
Description
Time to achieve blood pressure target
Time Frame
baseline to 6 months post procedure
Title
Change in sympathetic nerve activity
Description
Change in muscle sympathetic nerve activity, renal and whole body Noradrenaline (NA) spillover
Time Frame
baseline to 6 months post procedure
Title
Change in left ventricular structure and function
Description
Change in left Ventricular mass index, Ejection Fraction, diastolic filling
Time Frame
baseline to 6 months post procedure
Title
Change in Quality of life
Description
Change in Quality of life as assessed by relevant questionnaires
Time Frame
baseline to 6 months post procedure
Title
Change in serum and urine Biochemistry
Description
Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate(eGFR), Urinary Albumin Creatinine Ratio (UACR), inflammatory markers, 24hour urine creatinine clearance, sodium, fasting glucose, fasting insulin, c peptide, Homeostasis Model Assessment (HOMA) index, lipid profile.
Time Frame
baseline to 6 months post procedure
Title
Change in markers of arterial stiffness
Description
Change in markers of arterial stiffness including Augmentation Index (AI) and Pulse Wave Velocity (PWV)
Time Frame
baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes) Intolerance to ≥2 antihypertensive drug classes Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy Renal artery stenosis Chronic Kidney Disease Exclusion Criteria: renal artery anatomy ineligible for treatment individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit female participants of childbearing potential must have negative pregnancy test prior to treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus P Schlaich, MD
Organizational Affiliation
Baker IDI Heart & Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baker IDI Heart & Diabetes Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

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Renal Denervation for Complicated Hypertension

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