Clinical trial NCT02444442: Sham Controlled Clinical Trial of Renal Denervation in Patients With Resistant Hypertension
Official title: The Australian SHAM Controlled Clinical Trial of Renal DeNervation in Patients With Resistant Hypertension (AUSHAM-RDN-01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Renal denervation
Blood pressure
Cardiovascular risk
Target organ damage
Sympathetic activity
Non-compliance
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in ambulatory systolic blood pressure between groups
timeFrame: 6 months post procedure
Secondary outcomes:
measure: Change in mean 24h systolic blood pressure between groups
timeFrame: 6 months post procedure
measure: Change in mean night time systolic blood pressure between groups
timeFrame: 6 months post procedure
measure: Change in mean office systolic blood pressure between groups
timeFrame: 6 months post procedure
Other outcomes:
measure: Change in percentage of patients achieving BP target between groups
timeFrame: 6 months post procedure
measure: Change in percentage of patients with an ambulatory systolic BP reduction ≥5mmHg between groups
timeFrame: 6 months post procedure
measure: Change in percentage of patients with an office systolic BP reduction ≥10mmHg between groups
timeFrame: 6 months post procedure
measure: Change of sympathetic nerve activity between groups
timeFrame: 6 months post procedure
measure: Change in left ventricular function between groups
timeFrame: 6 months post procedure
measure: Change in Serum Biochemistry between groups
timeFrame: 6 months post procedure
measure: Change in Urine Biochemistry between groups
timeFrame: 6 months post procedure
measure: Change in Quality of Life between groups
timeFrame: 6 months post procedure
measure: Change in cognitive function between groups
timeFrame: 6 months post procedure
measure: Change in microRNA expression between groups
timeFrame: 6 months post procedure
Locations:
city: Melbourne
country: Australia
facility: Baker IDI Heart & Diabetes Institute
state: Victoria
Study officials:
affiliation: Laboratory Head, Neurovascular Hypertension and Kidney Disease (Baker IDI)
name: Markus P Schlaich, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pisano A, Iannone LF, Leo A, Russo E, Coppolino G, Bolignano D. Renal denervation for resistant hypertension. Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD011499. doi: 10.1002/14651858.CD011499.pub3.