Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865253
Recruitment Status : Terminated (No new participants enrolled. Protocol superseded.)
First Posted : May 30, 2013
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Baker IDI Heart and Diabetes Institute

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.


Condition or disease Intervention/treatment Phase
Hypertension Device: Renal Denervation Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation for Complicated Hypertension (RDNP-2012-03)
Study Start Date : May 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Renal Denervation
Renal Denervation treatment
Device: Renal Denervation
Renal Denervation
Other Name: Symplicity Renal Denervation Catheter




Primary Outcome Measures :
  1. Change in average office blood pressure [ Time Frame: baseline to 6 months post procedure ]
    Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure


Secondary Outcome Measures :
  1. Blood pressure control [ Time Frame: baseline to 6 months post procedure ]
    Percentage of patients who achieved BP target at 6 months post procedure

  2. Number of drugs required to reach target blood pressure [ Time Frame: baseline to 6 months post procedure ]
    Number of drugs required to reach target blood pressure

  3. Time to achieve blood pressure target [ Time Frame: baseline to 6 months post procedure ]
    Time to achieve blood pressure target

  4. Change in sympathetic nerve activity [ Time Frame: baseline to 6 months post procedure ]
    Change in muscle sympathetic nerve activity, renal and whole body Noradrenaline (NA) spillover

  5. Change in left ventricular structure and function [ Time Frame: baseline to 6 months post procedure ]
    Change in left Ventricular mass index, Ejection Fraction, diastolic filling

  6. Change in Quality of life [ Time Frame: baseline to 6 months post procedure ]
    Change in Quality of life as assessed by relevant questionnaires

  7. Change in serum and urine Biochemistry [ Time Frame: baseline to 6 months post procedure ]
    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.

  8. Change in markers of arterial stiffness [ Time Frame: baseline to 6 months ]
    Change in markers of arterial stiffness including Augmentation Index (AI) and Pulse Wave Velocity (PWV)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865253


Locations
Layout table for location information
Australia, Victoria
Baker IDI Heart & Diabetes Institute
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Baker IDI Heart and Diabetes Institute
Investigators
Layout table for investigator information
Principal Investigator: Markus P Schlaich, MD Baker IDI Heart & Diabetes Institute

Layout table for additonal information
Responsible Party: Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT01865253     History of Changes
Other Study ID Numbers: 087/12
1034397 ( Other Grant/Funding Number: NHMRC )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Keywords provided by Baker IDI Heart and Diabetes Institute:
renal denervation
blood pressure
cardiovascular risk
target organ damage
sympathetic activity
chronic kidney disease
non-compliance
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases