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Sham Controlled Clinical Trial of Renal Denervation in Patients With Resistant Hypertension

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ClinicalTrials.gov Identifier: NCT02444442
Recruitment Status : Unknown
Verified November 2018 by Baker Heart and Diabetes Institute.
Recruitment status was:  Recruiting
First Posted : May 14, 2015
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Baker Heart and Diabetes Institute

Brief Summary:

The purpose of this study is to assess the efficacy of catheter-based renal denervation in reducing blood pressure in patients with resistant hypertension compared to a sham procedure. Patients will be randomized to RDN or sham control in a 2:1 ratio. All participants will be switched to a single pill triple combination treatment prior to the procedure.

A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35 patients in the sham control arm.

The duration of this study is 36 months.


Condition or disease Intervention/treatment Phase
Hypertension Device: Renal Denervation Other: Sham control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Australian SHAM Controlled Clinical Trial of Renal DeNervation in Patients With Resistant Hypertension (AUSHAM-RDN-01)
Study Start Date : June 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Renal Denervation
participants randomised to undergo renal denervation
Device: Renal Denervation
Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries.

Sham Comparator: Sham control
participants randomised to undergo sham procedure
Other: Sham control
Arterial access only. No delivery of radio frequency energy to renal arteries.




Primary Outcome Measures :
  1. Change in ambulatory systolic blood pressure between groups [ Time Frame: 6 months post procedure ]
    Difference in mean ambulatory systolic daytime blood pressure between RDN group and sham-control group at 6 month follow up.


Secondary Outcome Measures :
  1. Change in mean 24h systolic blood pressure between groups [ Time Frame: 6 months post procedure ]
    Change in mean 24h systolic blood pressure between RDN group and sham-control group at 6 month follow up.

  2. Change in mean night time systolic blood pressure between groups [ Time Frame: 6 months post procedure ]
    Change in mean night time systolic blood pressure between RDN group and sham-control group at 6 month follow up.

  3. Change in mean office systolic blood pressure between groups [ Time Frame: 6 months post procedure ]
    Change in mean office systolic blood pressure between RDN group and sham-control group at 6 month follow up.


Other Outcome Measures:
  1. Change in percentage of patients achieving BP target between groups [ Time Frame: 6 months post procedure ]
    Change in percentage of patients achieving BP target between groups

  2. Change in percentage of patients with an ambulatory systolic BP reduction ≥5mmHg between groups [ Time Frame: 6 months post procedure ]
    Change in percentage of patients with an ambulatory systolic BP reduction ≥5mmHg between groups

  3. Change in percentage of patients with an office systolic BP reduction ≥10mmHg between groups [ Time Frame: 6 months post procedure ]
    Change in percentage of patients with an office systolic BP reduction ≥10mmHg between groups

  4. Change of sympathetic nerve activity between groups [ Time Frame: 6 months post procedure ]
    Change of sympathetic nerve activity (MSNA, renal and whole body NE spillover) between groups

  5. Change in left ventricular function between groups [ Time Frame: 6 months post procedure ]
    Change in left ventricular function (LV mass index, ejection fraction, diastolic filling) between groups

  6. Change in Serum Biochemistry between groups [ Time Frame: 6 months post procedure ]
    Plasma Renin Activity, aldosterone levels, estimated Glomerular Filtration Rate(eGFR), inflammatory markers, fasting glucose, fasting insulin, C-peptide, Homeostasis Model Assessment (HOMA) index, Lipid profile between groups

  7. Change in Urine Biochemistry between groups [ Time Frame: 6 months post procedure ]
    Urinary albumin creatinine ratio (UACR), 24 hour urinary creatinine clearance, sodium between groups

  8. Change in Quality of Life between groups [ Time Frame: 6 months post procedure ]
    Change in Quality of life as assessed by relevant questionnaires between groups

  9. Change in cognitive function between groups [ Time Frame: 6 months post procedure ]
    Change in cognitive function as assessed by relevant questionnaires and assessment tools between groups

  10. Change in microRNA expression between groups [ Time Frame: 6 months post procedure ]
    Change in microRNA expression as assessed by relevant assays between groups



Information from the National Library of Medicine

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

Inclusion Criteria:

  • systolic office BP ≥140mmHg and ambulatory day time average ≥135mmHg despite concurrent treatment with ≥3 anti-hypertensive drugs

Exclusion Criteria:

  • renal artery anatomy ineligible for treatment
  • eGFR <15mL/min/1.73m2 (using MDRD calculation)
  • myocardial infarction, unstable angina or cerebrovascular accident within 3 months of screening visit
  • life expectancy of <12 months
  • 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): NCT02444442


Contacts
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Contact: Markus P Schlaich, Professor +61 3 85321502 Markus.Schlaich@bakeridi.edu.au
Contact: Murray Esler, Professor +61 3 85321338 Murray.Esler@bakeridi.edu.au

Locations
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Australia, Victoria
Baker IDI Heart & Diabetes Institute Recruiting
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Baker Heart and Diabetes Institute
Investigators
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Principal Investigator: Markus P Schlaich, Professor Laboratory Head, Neurovascular Hypertension and Kidney Disease (Baker IDI)
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Responsible Party: Baker Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT02444442    
Other Study ID Numbers: 002/15
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Keywords provided by Baker Heart and Diabetes Institute:
Renal denervation
Blood pressure
Cardiovascular risk
Target organ damage
Sympathetic activity
Non-compliance
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases