HypertensionPhase 4RDNP-2012-03NCT01865253
Renal Denervation for Complicated 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 an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to: intolerance to antihypertensive medication inability to take antihypertensive medication due to planned pregnancy… 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
- 23 participants
- Where
- 1 siteAustralia
- Study dates
- May 2012to Mar 2015
- 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
- BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
- Intolerance to ≥2 antihypertensive drug classes
- Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy
- Renal artery stenosis
- Chronic Kidney Disease
Who cannot join
- renal artery anatomy ineligible for treatment
- individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
- 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: Renal Denervation for Complicated Hypertension (RDNP-2012-03)
This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to:
- intolerance to antihypertensive medication
- inability to take antihypertensive medication due to planned pregnancy
- renal artery stenosis
- chronic kidney disease
- non-compliance to antihypertensive medication
A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study.
The duration of this study is 36 months.
- Conditions
- Hypertension
- Being tested
- Renal Denervation
- Keywords
- renal denervation, blood pressure, cardiovascular risk, target organ damage, sympathetic activity, chronic kidney disease, non-compliance
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
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
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Renal Denervation treatment Receives: Device: Renal Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average office blood pressure
Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure
Measured: baseline to 6 months post procedure
Secondary outcomes (8)
Blood pressure control
Percentage of patients who achieved BP target at 6 months post procedure
Measured: baseline to 6 months post procedure
Number of drugs required to reach target blood pressure
Number of drugs required to reach target blood pressure
Measured: baseline to 6 months post procedure
Time to achieve blood pressure target
Time to achieve blood pressure target
Measured: baseline to 6 months post procedure
Change in sympathetic nerve activity
Change in muscle sympathetic nerve activity, renal and whole body Noradrenaline (NA) spillover
Measured: baseline to 6 months post procedure
Change in left ventricular structure and function
Change in left Ventricular mass index, Ejection Fraction, diastolic filling
Measured: baseline to 6 months post procedure
Change in Quality of life
Change in Quality of life as assessed by relevant questionnaires
Measured: baseline to 6 months post procedure
Change in serum and urine Biochemistry
Plasma renin activity, aldosterone, estimated Glomerular Filtration Rate(eGFR), Urinary Albumin Creatinine Ratio (UACR), inflammatory markers, 24hour urine creatinine clearance, sodium, fasting glucose, fasting insulin, c peptide, Homeostasis Model Assessment (HOMA) index, lipid profile.
Measured: baseline to 6 months post procedure
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 startMay 2012
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: No new participants enrolled. Protocol 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus P Schlaich, MD, Principal investigator, Baker IDI Heart & Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865253
- Sponsor's protocol ID
- 087/12
- Other IDs
- 1034397
- Acronym
- RDNP-2012-03
- 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 Complicated Hypertension (RDNP-2012-03)
- ClinicalTrials.gov ID
- NCT01865253
- Acronym / sponsor ID
- RDNP-2012-03 / 087/12
- Conditions
- Hypertension
- Keywords
- renal denervation, blood pressure, cardiovascular risk, target organ damage, sympathetic activity, chronic kidney disease, non-compliance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No new participants enrolled. Protocol superseded.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (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 an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to:
- intolerance to antihypertensive medication
- inability to take antihypertensive medication due to planned pregnancy
- renal artery stenosis
- chronic kidney disease
- non-compliance to antihypertensive medication
A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study.
The duration of this study is 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Device: Renal DenervationRenal Denervation treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
- Intolerance to ≥2 antihypertensive drug classes
- Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy
- Renal artery stenosis
- Chronic Kidney Disease
Key exclusion criteria (3 listed)
- renal artery anatomy ineligible for treatment
- individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
- 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 | Device | Renal Denervation |
Primary outcome
Change in average office blood pressure
Time frame: baseline to 6 months post procedure
Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure
8 secondary outcomes
Blood pressure control
Time frame: baseline to 6 months post procedure
Number of drugs required to reach target blood pressure
Time frame: baseline to 6 months post procedure
Time to achieve blood pressure target
Time frame: baseline to 6 months post procedure
Change in sympathetic nerve activity
Time frame: baseline to 6 months post procedure
Change in left ventricular structure and function
Time frame: baseline to 6 months post procedure
Change in Quality of life
Time frame: baseline to 6 months post procedure
Change in serum and urine Biochemistry
Time frame: baseline to 6 months post procedure
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 superseded.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
Related trials for Hypertension
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
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, 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 5 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 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?
Change in average office blood pressure (time frame: baseline to 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.