HypertensionNCT01442883
Renal Nerve Ablation in Chronic Kidney Disease Patients
An observational study of Hypertension and Chronic Kidney Disease, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
Trial summary
In patients with treatment resistent hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Chronic Kidney Disease
- What is being tested?
- Simplicity Catheter
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2010to Jun 2019
- Phase
- Observational
- 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
Study population: treatment resistant hypertensive adults with chronic kidney disease 3 - 5
Who may be able to join
- treatment resistant hypertension
- chronic kidney disease 3 - 5
- male of female aged over 18 years
- written informed consent
- agreement to attend all study visits as planned in the protocol
Who cannot join
- any contraindications for MRI
- claustrophobia
- strabismus
- severe ocular diseases
- history of epilepsia
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg
Erlangen, 91054
Joachim Weil
Lübeck
About this study
Official title: Understanding the Mechanisms of Progressive Decrease in Blood Pressure After Renal Nerve Ablation
In patients with treatment resistent hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labelling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction.
The investigators propose the following hypotheses why a progressive decrease in blood pressure happens, in addition to the decreased activity of the central nervous system, after renal nerve ablation:
Read more
Short term effects:
A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the kidney C)Exaggerated sodium excretion immediately after renal nerve ablation
Long term effects:
D)Decrease of total sodium content after 6 and 12 months. E)Improvement of vascular wall properties after 6 and 12 months
Read the detailed description
In patients with treatment resistent hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labelling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction.
- Conditions
- Hypertension, Chronic Kidney Disease
- Being tested
- Simplicity Catheter
- Keywords
- Treatment Resistant
- 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.
Simplicity CatheterDevice
percutaneous selective renal sympathetic nerve ablation with the use of the Simplicity Catheter system
| Study group | Role | What they receive |
|---|---|---|
| treatment resistant hypertensives with CKD 3-5 | Not described Receives: Device: Simplicity Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
office BP
Change in office blood pressure from baseline to 6 months post-renal nerve ablation
Measured: baseline, 6 months
24-h ABPM
Change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal nerve ablation
Measured: baseline, 6 months
Magnetic resonance imaging (MRI)
- change in total sodium content measured by MRI from baseline to 6 months post-renal nerve ablation
- change in renal perfusion measured by MRI spin labelling technique from baseline to 6 months post-renal nerve ablation
Measured: baseline, 6 months
Albuminuria
Change in urinary albumin/creatinine ratio from baseline to 6 months post renal nerve ablation (spot urine)
Measured: baseline, 6 months
local RAS activity
Change in urinary angiotensinogen concentration from the morning spot urine from baseline to 6 months post-renal nerve ablation
Measured: baseline, 6 months
systemic RAS activity
- change in sodium, potassium and creatinine from baseline to 6 months post-renal nerve ablation
- change in aldosterone excretion from baseline to 6 months post-renal nerve ablation
- change in sodium / potassium ratio from baseline to 6 months post-renal nerve ablation
- change in plasma renin activity and angiotensin II concentration at least 30 minutes of rest in a supine position and immediately after standing from baseline to 6 months post-renal nerve ablation
Measured: baseline, 6 months
vascular structure and function of large and small arteries
- change in flow-mediated vasodilation (FMD) from baseline to 6 months post-renal nerve ablation
- change in scanning laser Doppler flowmetry (SLDF) from baseline to 6 months post-renal nerve ablation
- change in pulse wave analysis (PWA) from baseline to 6 months post-renal nerve ablation
- change in pulse wave velocity from (PWV) baseline to 6 months post-renal nerve ablation
- change in urinary albumine creatinine ratio (UACR) of the morning spot urine sample from baseline to 6 months post-renal nerve ablation
Measured: baseline, 6 months
Secondary outcomes (5)
BP
- change in office blood pressure from baseline to 1 and 12 months post-renal nerve ablation
- change in 24 hour ambulatory blood pressure from baseline to 1 and 12 months post-renal nerve ablation
Measured: 1 and 12 months
local RAS activity
Change in urinary angiotensinogen concentration from the morning spot urine from baseline to 1 day and 1 months post-renal nerve ablation
Measured: 1 day and 1 months
systemic RAS activity
- change in sodium, potassium and creatinine from baseline to 1 day and 1 months post-renal nerve ablation
- change in albuminuria from baseline to 1 and 12 months post-renal nerve ablation
- change in aldosterone excretion from baseline to 1 day and 1 months post-renal nerve ablation
- change in sodium / potassium ratio from baseline to 1 day and 1 months post-renal nerve ablation
- change in plasma renin activity and angiotensin II concentration at least 30 minutes of rest in a supine position and immediately after standing from baseline to 1 day and 1 months post-renal nerve ablation
Measured: 1 day and 1 months
vascular structure and function of large and small arteries
- change in flow-mediated vasodilation (FMD) from baseline to 12 months post-renal nerve ablation
- change in scanning laser Doppler flowmetry (SLDF) from baseline to 12 months post-renal nerve ablation
- change in pulse wave analysis (PWA) from baseline to 12 months post-renal nerve ablation
- change in pulse wave velocity from (PWV) baseline to 12 months post-renal nerve ablation
- change in urinary albumine creatinine ratio (UACR) of the morning spot urine sample from baseline to 12 months post-renal nerve ablation
Measured: 12 months
MRI
- change in total sodium content measured by MRI from baseline to 12 months post-renal nerve ablation
- change in renal perfusion measured by MRI spin labelling technique from baseline to 1 day and 1 months post-renal nerve ablation
Measured: 1 day, 1 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland E Schmieder, MD, Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442883
- Sponsor's protocol ID
- RNA-CKD3-5
- Status last verified
- Mar 2020
- First submitted
- 22 Sep 2011
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmieder RE, Ott C, Schmid A, Friedrich S, Kistner I, Ditting T, Veelken R, Uder M, Toennes SW. Adherence to Antihypertensive Medication in Treatment-Resistant Hypertension Undergoing Renal Denervation. J Am Heart Assoc. 2016 Feb 12;5(2):e002343. doi: 10.1161/JAHA.115.002343.
PubMed 26873693Schmid A, Schmieder R, Lell M, Janka R, Veelken R, Schmieder RE, Uder M, Ott C. Mid-Term Vascular Safety of Renal Denervation Assessed by Follow-up MR Imaging. Cardiovasc Intervent Radiol. 2016 Mar;39(3):426-32. doi: 10.1007/s00270-015-1192-2. Epub 2015 Aug 8.
PubMed 26253780Ott C, Mahfoud F, Schmid A, Toennes SW, Ewen S, Ditting T, Veelken R, Ukena C, Uder M, Bohm M, Schmieder RE. Renal denervation preserves renal function in patients with chronic kidney disease and resistant hypertension. J Hypertens. 2015 Jun;33(6):1261-6. doi: 10.1097/HJH.0000000000000556.
PubMed 25923731
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Mechanisms of Progressive Decrease in Blood Pressure After Renal Nerve Ablation
- ClinicalTrials.gov ID
- NCT01442883
- Acronym / sponsor ID
- RNA-CKD3-5
- Conditions
- Hypertension, Chronic Kidney Disease
- Keywords
- Treatment Resistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 29 Sep 2011 (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.
In patients with treatment resistent hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labelling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction.
The investigators propose the following hypotheses why a progressive decrease in blood pressure happens, in addition to the decreased activity of the central nervous system, after renal nerve ablation:
Short term effects:
A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the kidney C)Exaggerated sodium excretion immediately after renal nerve ablation
Long term effects:
D)Decrease of total sodium content after 6 and 12 months. E)Improvement of vascular wall properties after 6 and 12 months
Detailed description
In patients with treatment resistent hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labelling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment resistant hypertensives with CKD 3-5 | – | Device: Simplicity Catheter |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- treatment resistant hypertensive adults with chronic kidney disease 3 - 5
Key inclusion criteria (5 listed)
- treatment resistant hypertension
- chronic kidney disease 3 - 5
- male of female aged over 18 years
- written informed consent
- agreement to attend all study visits as planned in the protocol
Key exclusion criteria (5 listed)
- any contraindications for MRI
- claustrophobia
- strabismus
- severe ocular diseases
- history of epilepsia
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 |
|---|---|---|
| Simplicity Catheterpercutaneous selective renal sympathetic nerve ablation with the use of the Simplicity Catheter system | Device | treatment resistant hypertensives with CKD 3-5 |
Primary outcome
office BP
Time frame: baseline, 6 months
Change in office blood pressure from baseline to 6 months post-renal nerve ablation
24-h ABPM
Time frame: baseline, 6 months
Change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal nerve ablation
Magnetic resonance imaging (MRI)
Time frame: baseline, 6 months
* change in total sodium content measured by MRI from baseline to 6 months post-renal nerve ablation * change in renal perfusion measured by MRI spin labelling technique from baseline to 6 months post-renal nerve ablation
Albuminuria
Time frame: baseline, 6 months
Change in urinary albumin/creatinine ratio from baseline to 6 months post renal nerve ablation (spot urine)
local RAS activity
Time frame: baseline, 6 months
Change in urinary angiotensinogen concentration from the morning spot urine from baseline to 6 months post-renal nerve ablation
systemic RAS activity
Time frame: baseline, 6 months
* change in sodium, potassium and creatinine from baseline to 6 months post-renal nerve ablation * change in aldosterone excretion from baseline to 6 months post-renal nerve ablation * change in sodium / potassium ratio from baseline to 6 months post-renal nerve ablation * change in plasma renin activity and angiotensin II concentration at least 30 minutes of rest in a supine position and immediately after standing from baseline to 6 months post-renal nerve ablation
vascular structure and function of large and small arteries
Time frame: baseline, 6 months
* change in flow-mediated vasodilation (FMD) from baseline to 6 months post-renal nerve ablation * change in scanning laser Doppler flowmetry (SLDF) from baseline to 6 months post-renal nerve ablation * change in pulse wave analysis (PWA) from baseline to 6 months post-renal nerve ablation * change in pulse wave velocity from (PWV) baseline to 6 months post-renal nerve ablation * change in urinary albumine creatinine ratio (UACR) of the morning spot urine sample from baseline to 6 months post-renal nerve ablation
5 secondary outcomes
BP
Time frame: 1 and 12 months
local RAS activity
Time frame: 1 day and 1 months
systemic RAS activity
Time frame: 1 day and 1 months
vascular structure and function of large and small arteries
Time frame: 12 months
MRI
Time frame: 1 day, 1 and 12 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 26 Mar 2020.
- Background: PubMed 26873693Schmieder RE, Ott C, Schmid A, Friedrich S, Kistner I, Ditting T, Veelken R, Uder M, Toennes SW. Adherence to Antihypertensive Medication in Treatment-Resistant Hypertension Undergoing Renal Denervation. J Am Heart Assoc. 2016 Feb 12;5(2):e002343. doi: 10.1161/JAHA.115.002343.
- Background: PubMed 26253780Schmid A, Schmieder R, Lell M, Janka R, Veelken R, Schmieder RE, Uder M, Ott C. Mid-Term Vascular Safety of Renal Denervation Assessed by Follow-up MR Imaging. Cardiovasc Intervent Radiol. 2016 Mar;39(3):426-32. doi: 10.1007/s00270-015-1192-2. Epub 2015 Aug 8.
- Derived from this study: PubMed 25923731Ott C, Mahfoud F, Schmid A, Toennes SW, Ewen S, Ditting T, Veelken R, Ukena C, Uder M, Bohm M, Schmieder RE. Renal denervation preserves renal function in patients with chronic kidney disease and resistant hypertension. J Hypertens. 2015 Jun;33(6):1261-6. doi: 10.1097/HJH.0000000000000556.
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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.
Roland E Schmieder, MD principal investigator
University of Erlangen-Nürnberg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Chronic Kidney Disease, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
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 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 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
office BP (time frame: baseline, 6 months). The study lists 7 primary outcomes in all. 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 NCT01442883, which also lists 3 linked publications.
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 26 Mar 2020.