HypertensionPhase 4RDNP-2012-01NCT01865240
Renal Denervation for Resistant Hypertension
A Phase 4 study testing Renal Denervation in people with Hypertension, run by Baker Heart and Diabetes Institute at 1 site in Australia.
Trial summary
This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. 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?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2012to Oct 2013
- Phase
- Phase 4
- 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 BP ≥140mmHg or ≥130mmHg for patients with diabetes
- concurrent treatment with ≥3 anti-hypertensive drugs
Who cannot join
- renal artery anatomy ineligible for treatment
- eGFR <15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)
- female participants of childbearing potential must have negative pregnancy test prior to treatment
Trial locations and contacts
1 site in 1 country.
About this study
This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.
Read the detailed description
Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.
- Conditions
- Hypertension
- Being tested
- Renal Denervation
- Keywords
- renal denervation, blood pressure, cardiovascular risk, target organ damage, sympathetic activity
- 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
Also called Symplicity Renal Denervation Catheter
Renal Denervation Catheter
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation Group | Experimental | participants randomised to undergo the renal denervation procedure Receives: Device: Renal Denervation |
| Usual care | No intervention | participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure control
percentage of patients to achieve Blood Pressure (BP) target (BP <140/90mmHg, or <130/80mmHg in diabetic patients) at 6 months post procedure
Measured: 6 months post procedure
Secondary outcomes (7)
number of drugs required to reach blood pressure target
number of drugs required to reach blood pressure target
Measured: baseline to 6 months
time to achieve blood pressure target
time to achieve blood pressure target
Measured: baseline to 6 months
Change in markers of sympathetic nerve activity
Changes in Muscle Sympathetic Nerve Activity (MSNA), renal and whole body Norepinephrine (NE) spillover
Measured: baseline to 6 months
Change in Left Ventricular Structure and Function
Change in Left Ventricular mass index, ejection fraction, diastolic filling as assessed by echocardiogram
Measured: baseline to 6 months
Change in Quality of Life
Change in Quality of Life as assessed by relevant questionnaires
Measured: baseline to 6 months
Serum and Urine Biochemistry
Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate (eGFR), urine albumin-to-creatinine ratio (UACR), inflammatory markers, 24hour urinary creatinine clearance, sodium, fasting glucose, fasting insulin, c-peptide, Homeostasis Model Assessment (HOMA) index, lipid profile
Measured: baseline to 6 months
Change in markers of arterial stiffness
Change in markers of arterial stiffness including Augmentation Index (AI) and Pulse Wave Velocity (PWV)
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: No new participants enrolled. Protocol has been superseded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Schlaich, MD, Principal investigator, Baker IDI Heart & Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865240
- Sponsor's protocol ID
- 008/12
- Other IDs
- NHMRC
- Acronym
- RDNP-2012-01
- Status last verified
- Nov 2018
- First submitted
- 27 May 2013
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation for Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01865240
- Acronym / sponsor ID
- RDNP-2012-01 / 008/12
- Conditions
- Hypertension
- Keywords
- renal denervation, blood pressure, cardiovascular risk, target organ damage, sympathetic activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No new participants enrolled. Protocol has been superseded
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 May 2013 (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.
This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.
Detailed description
Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation Group | Experimental | Device: Renal Denervationparticipants randomised to undergo the renal denervation procedure |
| Usual care | No intervention | –participants randomised to the usual care group will receive additional antihypertensive medication in an attempt to achieve blood pressure targets |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- systolic BP ≥140mmHg or ≥130mmHg for patients with diabetes
- concurrent treatment with ≥3 anti-hypertensive drugs
Key exclusion criteria (3 listed)
- renal artery anatomy ineligible for treatment
- eGFR <15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)
- 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 DenervationAlso: Symplicity Renal Denervation CatheterRenal Denervation Catheter | Device | Renal Denervation Group |
Primary outcome
blood pressure control
Time frame: 6 months post procedure
percentage of patients to achieve Blood Pressure (BP) target (BP <140/90mmHg, or <130/80mmHg in diabetic patients) at 6 months post procedure
7 secondary outcomes
number of drugs required to reach blood pressure target
Time frame: baseline to 6 months
time to achieve blood pressure target
Time frame: baseline to 6 months
Change in markers of sympathetic nerve activity
Time frame: baseline to 6 months
Change in Left Ventricular Structure and Function
Time frame: baseline to 6 months
Change in Quality of Life
Time frame: baseline to 6 months
Serum and Urine Biochemistry
Time frame: baseline to 6 months
Change in markers of arterial stiffness
Time frame: baseline to 6 months
Results and safety
The study was stopped early (reason given: No new participants enrolled. Protocol has been superseded). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
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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 Schlaich, MD principal investigator
Baker IDI Heart & Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Nov 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No new participants enrolled. Protocol has been superseded). Results are not available in the source record.
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?
blood pressure control (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?
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 5 Nov 2018.