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Renal Denervation for Resistant Hypertension (RDNP-2012-01)

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

Eligibility Criteria

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

Inclusion Criteria:

  • systolic BP ≥140mmHg or ≥130mmHg for patients with diabetes
  • concurrent treatment with ≥3 anti-hypertensive drugs

Exclusion Criteria:

  • renal artery anatomy ineligible for treatment
  • eGFR <15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)
  • female participants of childbearing potential must have negative pregnancy test prior to treatment

Sites / Locations

  • Baker IDI Heart & Diabetes Inst

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Renal Denervation Group

Usual care

Arm Description

participants randomised to undergo the renal denervation procedure

participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets

Outcomes

Primary Outcome Measures

blood pressure control
percentage of patients to achieve Blood Pressure (BP) target (BP <140/90mmHg, or <130/80mmHg in diabetic patients) at 6 months post procedure

Secondary Outcome Measures

number of drugs required to reach blood pressure target
number of drugs required to reach blood pressure target
time to achieve blood pressure target
time to achieve blood pressure target
Change in markers of sympathetic nerve activity
Changes in Muscle Sympathetic Nerve Activity (MSNA), renal and whole body Norepinephrine (NE) spillover
Change in Left Ventricular Structure and Function
Change in Left Ventricular mass index, ejection fraction, diastolic filling as assessed by echocardiogram
Change in Quality of Life
Change in Quality of Life as assessed by relevant questionnaires
Serum and Urine Biochemistry
Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate (eGFR), urine albumin-to-creatinine ratio (UACR), inflammatory markers, 24hour urinary 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
NCT01865240
Brief Title
Renal Denervation for Resistant Hypertension
Acronym
RDNP-2012-01
Official Title
Renal Denervation for Resistant Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
No new participants enrolled. Protocol has been superseded
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (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 a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.
Detailed Description
Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation Group
Arm Type
Experimental
Arm Description
participants randomised to undergo the renal denervation procedure
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets
Intervention Type
Device
Intervention Name(s)
Renal Denervation
Other Intervention Name(s)
Symplicity Renal Denervation Catheter
Intervention Description
Renal Denervation Catheter
Primary Outcome Measure Information:
Title
blood pressure control
Description
percentage of patients to achieve Blood Pressure (BP) target (BP <140/90mmHg, or <130/80mmHg in diabetic patients) at 6 months post procedure
Time Frame
6 months post procedure
Secondary Outcome Measure Information:
Title
number of drugs required to reach blood pressure target
Description
number of drugs required to reach blood pressure target
Time Frame
baseline to 6 months
Title
time to achieve blood pressure target
Description
time to achieve blood pressure target
Time Frame
baseline to 6 months
Title
Change in markers of sympathetic nerve activity
Description
Changes in Muscle Sympathetic Nerve Activity (MSNA), renal and whole body Norepinephrine (NE) spillover
Time Frame
baseline to 6 months
Title
Change in Left Ventricular Structure and Function
Description
Change in Left Ventricular mass index, ejection fraction, diastolic filling as assessed by echocardiogram
Time Frame
baseline to 6 months
Title
Change in Quality of Life
Description
Change in Quality of Life as assessed by relevant questionnaires
Time Frame
baseline to 6 months
Title
Serum and Urine Biochemistry
Description
Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate (eGFR), urine albumin-to-creatinine ratio (UACR), inflammatory markers, 24hour urinary creatinine clearance, sodium, fasting glucose, fasting insulin, c-peptide, Homeostasis Model Assessment (HOMA) index, lipid profile
Time Frame
baseline to 6 months
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: systolic BP ≥140mmHg or ≥130mmHg for patients with diabetes concurrent treatment with ≥3 anti-hypertensive drugs Exclusion Criteria: renal artery anatomy ineligible for treatment eGFR <15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation) female participants of childbearing potential must have negative pregnancy test prior to treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Schlaich, MD
Organizational Affiliation
Baker IDI Heart & Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baker IDI Heart & Diabetes Inst
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

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Renal Denervation for Resistant Hypertension

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