HypertensionNCT02444442
Sham Controlled Clinical Trial of Renal Denervation in Patients With Resistant Hypertension
A study testing Renal Denervation in people with Hypertension, run by Baker Heart and Diabetes Institute at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Renal Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2015to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- systolic office BP ≥140mmHg and ambulatory day time average ≥135mmHg despite concurrent treatment with ≥3 anti-hypertensive drugs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Baker IDI Heart & Diabetes Institute
Melbourne, Victoria, 3004
About this study
Official title: The Australian SHAM Controlled Clinical Trial of Renal DeNervation in Patients With Resistant Hypertension (AUSHAM-RDN-01)
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.
- Conditions
- Hypertension
- Being tested
- Renal Denervation, Sham control
- Keywords
- Renal denervation, Blood pressure, Cardiovascular risk, Target organ damage, Sympathetic activity, Non-compliance
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DenervationDevice
Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries.
Sham controlOther
Arterial access only. No delivery of radio frequency energy to renal arteries.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Active comparator | participants randomised to undergo renal denervation Receives: Device: Renal Denervation |
| Sham control | Sham comparator | participants randomised to undergo sham procedure Receives: Other: Sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ambulatory systolic blood pressure between groups
Difference in mean ambulatory systolic daytime blood pressure between RDN group and sham-control group at 6 month follow up.
Measured: 6 months post procedure
Secondary outcomes (3)
Change in mean 24h systolic blood pressure between groups
Change in mean 24h systolic blood pressure between RDN group and sham-control group at 6 month follow up.
Measured: 6 months post procedure
Change in mean night time systolic blood pressure between groups
Change in mean night time systolic blood pressure between RDN group and sham-control group at 6 month follow up.
Measured: 6 months post procedure
Change in mean office systolic blood pressure between groups
Change in mean office systolic blood pressure between RDN group and sham-control group at 6 month follow up.
Measured: 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus P Schlaich, Professor, Principal investigator, Laboratory Head, Neurovascular Hypertension and Kidney Disease (Baker IDI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444442
- Sponsor's protocol ID
- 002/15
- Status last verified
- Sep 2023
- First submitted
- 12 May 2015
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34806762
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Australian SHAM Controlled Clinical Trial of Renal DeNervation in Patients With Resistant Hypertension (AUSHAM-RDN-01)
- ClinicalTrials.gov ID
- NCT02444442
- Acronym / sponsor ID
- 002/15
- Conditions
- Hypertension
- Keywords
- Renal denervation, Blood pressure, Cardiovascular risk, Target organ damage, Sympathetic activity, Non-compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Active comparator | Device: Renal Denervationparticipants randomised to undergo renal denervation |
| Sham control | Sham comparator | Other: Sham controlparticipants randomised to undergo sham procedure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- systolic office BP ≥140mmHg and ambulatory day time average ≥135mmHg despite concurrent treatment with ≥3 anti-hypertensive drugs
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal DenervationDeliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries. | Device | Renal Denervation |
| Sham controlArterial access only. No delivery of radio frequency energy to renal arteries. | Other | Sham control |
Primary outcome
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.
3 secondary outcomes
Change in mean 24h systolic blood pressure between groups
Time frame: 6 months post procedure
Change in mean night time systolic blood pressure between groups
Time frame: 6 months post procedure
Change in mean office systolic blood pressure between groups
Time frame: 6 months post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Derived from this study: PubMed 34806762Pisano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus P Schlaich, Professor principal investigator
Laboratory Head, Neurovascular Hypertension and Kidney Disease (Baker IDI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Denervation in people with Hypertension, run by Baker Heart and Diabetes Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ambulatory systolic blood pressure between groups (time frame: 6 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.