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NCT Number: NCT02444442

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baker IDI Heart & Diabetes Institute

Melbourne, Victoria, 3004, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal Denervation

Device

Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries.

Sham control

Other

Arterial access only. No delivery of radio frequency energy to renal arteries.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Baker Heart and Diabetes Institute

Other

Registry information

Official study title

The Australian SHAM Controlled Clinical Trial of Renal DeNervation in Patients With Resistant Hypertension (AUSHAM-RDN-01)

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 14, 2015
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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