HypertensionNCT02863510
Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease
A study testing Renal Sympathetic Denervation in people with Hypertension and Chronic Kidney Disease, run by Heart of England NHS Trust at 1 site in United Kingdom.
Trial summary
A pilot, single-center, prospective, interventional study. The objective is to demonstrate that catheter-based renal denervation using carbon dioxide renal angiography in patients with moderate to severe chronic kidney disease can be performed for treatment of uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Chronic Kidney Disease
- What is being tested?
- Renal Sympathetic Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Jul 2016
- 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
- Patients aged 18-75 years with a clinic systolic blood pressure of 140 mm Hg or more despite compliance with three or more antihypertensive drugs,
- eGFR<45 and >15 mL/min per 1.73 m².
Who cannot join
- eGFR <15 mL/min per 1.73 m²,
- Type 1 diabetes,
- Substantial stenotic valvular heart disease,
- Pregnancy or planned pregnancy during the study,
- A history of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 6 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Heart of England NHS Foundation Trust
Birmingham, West Midlands, B9 5SS
About this study
Official title: Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease Using a Novel Non-iodinated Contrast Free Protocol
A pilot, single-center, prospective, interventional study. The objective is to demonstrate that catheter-based renal denervation using carbon dioxide renal angiography in patients with moderate to severe chronic kidney disease can be performed for treatment of uncontrolled hypertension.
Read the detailed description
Renal sympathetic denervation has been shown to be safe and effective in patients with uncontrolled hypertension and estimated Glomerular Filtration Rate (eGFR)>45 mL/min per 1•73 m². However, the safety and efficacy of this has not been studied in patients with more severe renal impairment. The investigators aim to examine safety and efficacy of renal denervation (RDN) in patients with eGFR between 44 and 15 ml/min/1.73 m2 (CKD 3b \& 4) in a pilot study which may be a precursor of a large observational study in the future. Moreover, the current imaging protocol and procedure protocol for renal sympathetic denervation requires the use of iodinated contrast, which can have deleterious effects on renal function. The investigators have a proven track record for the use of carbon dioxide angiography in renal artery intervention. The investigators would like to use carbon dioxide angiography in this study to minimize contrast induced deterioration in renal function in this cohort which may again be a precursor of a farther larger study.
- Conditions
- Hypertension, Chronic Kidney Disease
- Being tested
- Renal Sympathetic Denervation
- Keywords
- Carbon dioxide angiography, Renal sympathetic denervation, Uncontrolled hypertension, Chronic kidney disease
- 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 Sympathetic DenervationDevice
Renal sympathetic denervation is a minimally invasive, endovascular catheter-based procedure using radiofrequency ablation of sympathetic nerves located in the walls of renal arteries, aimed at treating treatment-resistant hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Participation receiving renal sympathetic denervation Receives: Device: Renal Sympathetic Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Estimated glomerular filtration rate from baseline to 7 days and 30 days
Change in eGFR from baseline to 7 days and 1 month as measure of safety in terms of kidney function
Measured: at baseline, 7days and 30 days
Secondary outcomes (4)
Change in estimated glomerular filtration rate from baseline to 7 days, 1, 3, and 6 months
Change in kidney function from baseline to 7 days, 1, 3, and 6 months
Measured: at baseline, 7 days, 1, 3, and 6 months
Change in proteinuria (albumin:creatinine ratio) from baseline to at 1, 3, and 6 months.
Change in proteinuria (albumin:creatinine ratio) from baseline to at 1, 3, and 6 months.
Measured: at baseline, 1, 3, and 6 months
Change in mean daytime ambulatory blood pressure on 24 hour monitoring from baseline to 6 months
Change in mean daytime ambulatory blood pressure on 24 hour monitoring from baseline to 6 months
Measured: at baseline and 6 months
Change in office blood pressure from baseline to 1,3, and 6 months
Change in office BP from baseline to 1,3, and 6 months for efficacy
Measured: at baseline, 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startSep 2013
- Primary completionJul 2016
- Study completionJul 2016
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart of England NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Indranil Dasgupta, DM, Principal investigator, Heart of England NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863510
- Sponsor's protocol ID
- 2012138RN
- Status last verified
- Aug 2017
- First submitted
- 12 Feb 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Sympathetic Denervation in Moderate to Severe Chronic Kidney Disease Using a Novel Non-iodinated Contrast Free Protocol
- ClinicalTrials.gov ID
- NCT02863510
- Acronym / sponsor ID
- 2012138RN
- Conditions
- Hypertension, Chronic Kidney Disease
- Keywords
- Carbon dioxide angiography, Renal sympathetic denervation, Uncontrolled hypertension, Chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Heart of England NHS TrustUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Aug 2016 (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.
A pilot, single-center, prospective, interventional study. The objective is to demonstrate that catheter-based renal denervation using carbon dioxide renal angiography in patients with moderate to severe chronic kidney disease can be performed for treatment of uncontrolled hypertension.
Detailed description
Renal sympathetic denervation has been shown to be safe and effective in patients with uncontrolled hypertension and estimated Glomerular Filtration Rate (eGFR)>45 mL/min per 1•73 m². However, the safety and efficacy of this has not been studied in patients with more severe renal impairment. The investigators aim to examine safety and efficacy of renal denervation (RDN) in patients with eGFR between 44 and 15 ml/min/1.73 m2 (CKD 3b \& 4) in a pilot study which may be a precursor of a large observational study in the future. Moreover, the current imaging protocol and procedure protocol for renal sympathetic denervation requires the use of iodinated contrast, which can have deleterious effects on renal function. The investigators have a proven track record for the use of carbon dioxide angiography in renal artery intervention. The investigators would like to use carbon dioxide angiography in this study to minimize contrast induced deterioration in renal function in this cohort which may again be a precursor of a farther larger study.
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 Sympathetic DenervationParticipation receiving renal sympathetic denervation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-75 years with a clinic systolic blood pressure of 140 mm Hg or more despite compliance with three or more antihypertensive drugs,
- eGFR<45 and >15 mL/min per 1.73 m².
Key exclusion criteria (5 listed)
- eGFR <15 mL/min per 1.73 m²,
- Type 1 diabetes,
- Substantial stenotic valvular heart disease,
- Pregnancy or planned pregnancy during the study,
- A history of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 6 months.
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 Sympathetic DenervationRenal sympathetic denervation is a minimally invasive, endovascular catheter-based procedure using radiofrequency ablation of sympathetic nerves located in the walls of renal arteries, aimed at treating treatment-resistant hypertension. | Device | Renal Denervation |
Primary outcome
Change in Estimated glomerular filtration rate from baseline to 7 days and 30 days
Time frame: at baseline, 7days and 30 days
Change in eGFR from baseline to 7 days and 1 month as measure of safety in terms of kidney function
4 secondary outcomes
Change in estimated glomerular filtration rate from baseline to 7 days, 1, 3, and 6 months
Time frame: at baseline, 7 days, 1, 3, and 6 months
Change in proteinuria (albumin:creatinine ratio) from baseline to at 1, 3, and 6 months.
Time frame: at baseline, 1, 3, and 6 months
Change in mean daytime ambulatory blood pressure on 24 hour monitoring from baseline to 6 months
Time frame: at baseline and 6 months
Change in office blood pressure from baseline to 1,3, and 6 months
Time frame: at baseline, 1, 3, and 6 months
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 9 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Indranil Dasgupta, DM principal investigator
Heart of England NHS Foundation Trust
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 Sympathetic Denervation in people with Hypertension and Chronic Kidney Disease, run by Heart of England NHS Trust at 1 site in United Kingdom.
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 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 9 Aug 2017. 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 United Kingdom. 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?
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 Estimated glomerular filtration rate from baseline to 7 days and 30 days (time frame: at baseline, 7days and 30 days). 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 9 Aug 2017.