Uncontrolled HypertensionRDNNCT02164435
Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation
A study testing Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System. in people with Uncontrolled Hypertension, run by University of Adelaide at 1 site in Australia.
Trial summary
This is a prospective, single centre clinical investigation looking at short (6 months) and long term (24 months) changes in cardiac function and renal function in patients with drug-resistant hypertension post renal sympathetic denervation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2013to Oct 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be able and willing to comply with the required follow-up schedule
- Therapeutic Goods Association approved indications for EnligHTN™ Renal Denervation System
- Subject is ≥ 18 years of age at time of consent Subject has office SBP ≥ 160 mmHg (except for subjects with Diabetes Mellitus who must demonstrate an office SBP of ≥ 150 mm Hg) within 14 days of the procedure ◦Subject is taking ≥ 3 antihypertensive medications concurrently at maximum tolerated dose (this must include one diuretic) or subject has a documented intolerance to at least 2 out of the 4 major classes of anti-hypertensives (ACE/ARB, CCB, Diuretics, Beta Blockers and is unable to take 3 antihypertensive drugs.
Who cannot join
- Standard CMR exclusions;
- implanted cardiac device
- intracranial metallic implants
- claustrophobia -Gadolinium-specific: estimated GFR <60 mls/min (usual clinical cut-off is <30 mls/min).
- Adenosine-specific:
- asthma / reactive airways disease
Show all 16Show fewer
- >first degree atrioventricular block
- concomitant use of dipyridamole or theophylline consumption of caffeine within 48 hours of proposed investigation
- EnligHTN™ Renal Denervation System exclusion criteria:
- Subject has an identified cause of secondary hypertension
- Subject has an estimated GFR <45 mL/min per 1.73 m2 using the MDRD formula
- Subject has undergone prior renal angioplasty, indwelling renal stents, and/or aortic stent grafts
- Subject has haemodynamically significant valvular heart disease
- Subject has a life expectancy less than 12 months, as determined by the PI
- Subject is participating in another clinical study Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
- Subject has renal arteries with diameter(s) < 4 mm in diameter
Trial locations and contacts
1 site in 1 country.
Stephen G Worthley, Prof contact
Australia1 site, 1 recruiting
- Recruiting
Royal Adelaide Hospital Adelaide
Adelaide, South Australia, 5000
Joanne Nimmo, 08 8222 2899, joanne.nimmo@health.sa.gov.au
Stephen Worthley, Prof
About this study
This is a prospective, single centre clinical investigation looking at short (6 months) and long term (24 months) changes in cardiac function and renal function in patients with drug-resistant hypertension post renal sympathetic denervation.
- Conditions
- Uncontrolled Hypertension
- Being tested
- Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.
- Keywords
- Uncontrolled hypertension, Renal denervation, Renal artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Other | Not described Receives: Procedure: Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Function (evaluated by MRI)
MRI Indices of Cardiac Function
- Myocardial mass and myocardial fibrosis
- Atrial and ventricular ejection function
- Myocardial perfusion
- Arterial distensibility
Measured: Baseline and 6 Months
Secondary outcomes (2)
Renal Function (evaluated by MRI)
MRI Indices of Renal Function:
- Renal blood flow
- Renal perfusion
- Urinary protein
Measured: Baseline, 6 Months and 24 Months
Cardiac Function
MRI Indices of Cardiac Function
- Myocardial mass and myocardial fibrosis
- Atrial and ventricular ejection function
- Myocardial perfusion
- Arterial distensibility
Measured: Baseline and 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2014 (estimated)
- Study completionOct 2015 (estimated)
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 Uncontrolled 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Grant Worthley, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164435
- Sponsor's protocol ID
- CI-12-044-AU-HT
- Acronym
- RDN
- Status last verified
- Jun 2014
- First submitted
- 12 Jun 2014
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Delacroix S, Chokka RG, Nelson AJ, Wong DT, Pederson S, Nimmo J, Rajwani A, Williams K, Teo KS, Worthley SG. Effects of renal sympathetic denervation on myocardial structure, function and perfusion: A serial CMR study. Atherosclerosis. 2018 May;272:207-215. doi: 10.1016/j.atherosclerosis.2018.03.022. Epub 2018 Mar 10.
PubMed 29627741
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation
- ClinicalTrials.gov ID
- NCT02164435
- Acronym / sponsor ID
- RDN / CI-12-044-AU-HT
- Conditions
- Uncontrolled Hypertension
- Keywords
- Uncontrolled hypertension, Renal denervation, Renal artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 16 Jun 2014 (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 prospective, single centre clinical investigation looking at short (6 months) and long term (24 months) changes in cardiac function and renal function in patients with drug-resistant hypertension post renal sympathetic denervation.
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 | Other | Procedure: Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must be able and willing to comply with the required follow-up schedule
- Therapeutic Goods Association approved indications for EnligHTN™ Renal Denervation System
- Subject is ≥ 18 years of age at time of consent Subject has office SBP ≥ 160 mmHg (except for subjects with Diabetes Mellitus who must demonstrate an office SBP of ≥ 150 mm Hg) within 14 days of the procedure ◦Subject is taking ≥ 3 antihypertensive medications concurrently at maximum tolerated dose (this must include one diuretic) or subject has a documented intolerance to at least 2 out of the 4 major classes of anti-hypertensives (ACE/ARB, CCB, Diuretics, Beta Blockers and is unable to take 3 antihypertensive drugs.
Key exclusion criteria (16 listed)
- Standard CMR exclusions;
- Adenosine-specific:
- Subject has an identified cause of secondary hypertension
- Subject has an estimated GFR <45 mL/min per 1.73 m2 using the MDRD formula
- Subject has undergone prior renal angioplasty, indwelling renal stents, and/or aortic stent grafts
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 Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System. | Procedure or surgery | Renal Denervation |
Primary outcome
Cardiac Function (evaluated by MRI)
Time frame: Baseline and 6 Months
MRI Indices of Cardiac Function * Myocardial mass and myocardial fibrosis * Atrial and ventricular ejection function * Myocardial perfusion * Arterial distensibility
2 secondary outcomes
Renal Function (evaluated by MRI)
Time frame: Baseline, 6 Months and 24 Months
Cardiac Function
Time frame: Baseline and 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
- Derived from this study: PubMed 29627741Delacroix S, Chokka RG, Nelson AJ, Wong DT, Pederson S, Nimmo J, Rajwani A, Williams K, Teo KS, Worthley SG. Effects of renal sympathetic denervation on myocardial structure, function and perfusion: A serial CMR study. Atherosclerosis. 2018 May;272:207-215. doi: 10.1016/j.atherosclerosis.2018.03.022. Epub 2018 Mar 10.
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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.
Stephen G Worthley, Prof contact
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 (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System. in people with Uncontrolled Hypertension, run by University of Adelaide 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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 16 Jun 2014. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen G Worthley, Prof (stephen.worthley@adelaide.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Function (evaluated by MRI) (time frame: Baseline and 6 Months). 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 NCT02164435, 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 16 Jun 2014.