HypertensionNCT01427049
The Effect of Renal Denervation on Biological Variables
An observational study of Hypertension, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Hypertension is a major and growing public health concern. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a major contributor to the complex pathophysiology of (essential) hypertension. The renal sympathetic nerves play a major role in the elevation of the SNS activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- renal denervation
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2011to Feb 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a systolic BP ≥160 mmHg (≥150 mmHg for type 2 diabetics) with a stable drug regimen including 3 or more antihypertensive medications, including a diuretic, or inability to follow a stable drug regimen due to unacceptable side-effects of antihypertensive medication. This current study is an observational exploratory-study.
Who may be able to join
- Individual has a systolic BP ≥160 mmHg (≥150 mmHg for type 2 diabetics) based on an average of 3 office BP readings measured according to the guidelines in appendix A.
- Individual is adhering to a stable drug regimen including 3 or more antihypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrolment) which is expected to be maintained for at least 6 months. Or:
- Has experienced side effects to several anti-hypertensive medications
- Individual is ≥18 years of age.
- Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
Who cannot join
- Individual has a treatable secondary cause of hypertension. (it is possible that during baseline procedures secondary causes of hypertension are discovered, those individuals will be excluded from participation of the study.)
- Individual has renal artery anatomy that is ineligible for treatment including:
- Main renal arteries < 4 mm in diameter or < 20 mm in length.
- Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets standards for surgical repair or interventional dilation.
- A history of prior renal artery stenting.
- Multiple main renal arteries in either kidney.
Show all 26Show fewer
- Individual has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2, using the MDRD calculation.
- Individual has type 1 diabetes mellitus.
- Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- Individual has scheduled or planned surgery or cardiovascular intervention in the next 6 months.
- Individual has hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous.
- Individual has an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for RF energy delivery.
- Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, or significant anaemia, or arrhythmias such as atrial fibrillation).
- Individual is pregnant, nursing or planning to be pregnant.
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Individual is currently enrolled in another investigational drug or device trial.
- Individual is currently being treated with any of the following medications:
- Drugs that cause salt retention (e.g., systemic corticosteroids and fludrocortisone)
- Warfarin or phenprocoumon that cannot be temporarily stopped for the procedure.
- Any contraindications for MRI:
- The presence of implanted cardiac pacemakers and/or auto-implanted cardioverter defibrillators.
- Mechanical cardiac valves.
- Implanted electronic devices like cochlear implants and nerve stimulators.
- Patients who are unable to fit into the bore of the magnet.
- Claustrophobia.
- Prosthesis of a joint.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Renal Denervation on Several Biological Variables in Patients With Uncontrolled Hypertension. An Observational Feasibility Study.
Hypertension is a major and growing public health concern. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a major contributor to the complex pathophysiology of (essential) hypertension. The renal sympathetic nerves play a major role in the elevation of the SNS activity. Therapeutic renal denervation (RD), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity - both by reducing the sympathetic modulation of renal function (renin release, sodium excretion and renal blood flow) and by removing the renal afferent sympathetic contribution to central blood pressure elevation.
This current study is an observational exploratory study. The main objective of this study is to learn more on the effects of RD. We wish to do that by quantifying the effects of RD on various biological variables. Those variables are studied in four sets of investigations: a radiological set, a laboratorial set, a set of blood pressure measurements and a set of investigations in the vascular laboratory. The radiological set consists of imaging of the heart and kidney function (renal perfusion) and structure (renal arteries), the laboratorial set of serum and urine tests, 24 h- home- and office- blood pressure measurements will be taken and finally the set of vascular tests contains investigations on pulse wave velocity(PWV) and heart rate variability(HRV). The data will most likely help us to define future studies, to describe the mode of action and the effects of RD on various organs and systems in more detail, and finally to define in more detail which type of hypertensive patients is especially likely to benefit of the procedure.
Read more
Hypothesis:
- We hypothesize that LV mass will decrease after RD. Because all patients have severe hypertension, it is likely that a substantial percentage will have increased LV mass.
- We hypothesize that renal perfusion and renal oxygenation increase after RD.
- We hypothesize that there will be no complications related to the device or procedure.
- We hypothesize that renal denervation has a beneficial effect on insulin resistance
- We hypothesize that renal denervation will decrease the blood pressure(office and 24-hour-measurements)
- We hypothesize that RD has a beneficial effect on PWV and HRV.
Read the detailed description
Objective: The objectives of this study are: the investigation of changes in left ventricular mass (LV mass) after RD using MRI, renal perfusion and renal oxygenation after RD using dynamic contrast enhanced MRI (DCE MRI)and blood oxygenation level dependent MRI (BOLD MRI), the evaluation of safety of RD, in terms of structural changes in the renal arteries and kidney using Magnetic resonance angiography (MRA). Secondly the evaluation of changes in various biological functions assessed by analysis of blood and/or urine samples. Thirdly the quantification of changes in blood pressure. Finally the changes in pulse wave velocity (PWV) and heart rate variability (HRV).
Study design: Observational exploratory-study.
Study population: Adults with a systolic BP ≥160 mmHg (≥150 mmHg for type 2 diabetics) with a stable drug regimen including 3 or more antihypertensive medications, including a diuretic, or inability to follow a stable drug regimen due to unacceptable side-effects of antihypertensive medication.
Main study parameters/endpoints: The effect of RD on: radiological variables: left ventricular wall mass, renal perfusion, renal oxygenation and the anatomy of the renal arteries. Secondly the effect of RD on biological variables assessed by analysis of blood and/or urine samples. Thirdly the changes in blood pressure. Finally the changes in PWV and HRV after RD.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with the tests and procedures performed for the clinical study are limited. There are no known risks associated with MRI when appropriate safety guidelines are followed. Based on the experience form our previous studies, we do not expect any potential risks regarding the cessation of anti-hypertensives.
- Conditions
- Hypertension
- Being tested
- renal denervation
- Keywords
- renal denervation, renal sympathetic denervation, renal ablation, resistant hypertension, hypertension, renal oxygenation, renal perfusion
- 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 Catheter system
percutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system
| Study group | Role | What they receive |
|---|---|---|
| renal denervation | Adults with a systolic BP ≥160 mmHg (≥150 mmHg for type 2 diabetics) with a stable drug regimen including 3 or more antihypertensive medications, including a diuretic, or inability to follow a stable drug regimen due to unacceptable side-effects of antihypertensive medication. Receives: Device: renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood pressure related endpoints:
- Incidence of achieving target systolic blood pressure(SBP) (SBP <140 mmHg, or <130 for diabetics)
- Incidence of achieving a >10 mmHg reduction in SBP
- Change in office BP from baseline to 6 months post-renal denervation.
- Change in 24 hour ambulatory blood pressure taken without the use of antihypertensive medication, from baseline to 12 months post-renal denervation.
- Changes in SBP and diastolic blood pressure (DBP) from baseline to 6 and 12 months
Measured: t=0, t=6 and t=12 months
Secondary outcomes (10)
Radiologic endpoint
- The change in left ventricular mass -determined by balanced SSFP cine MRI - after renal denervation compared with baseline. This change will be expressed in grams and grams per square meter of body surface area.
Measured: t=0 and t=12 months
radiologic endpoint
The change of renal perfusion 12 months after renal denervation compared to baseline. Dynamic contrast-enhanced MRI will be used for quantitative assessment of renal perfusion. Renal perfusion will be calculated in mL/gram/min.
Measured: t=0 and t=12 months
radiologic endpoint
The change of renal oxygenation after renal denervation compared to baseline; Changes in oxygenation are calculated in changes in T2 * ratio (i.e. T2 * cortex/ T2 * medulla).
Measured: t=0 and t=12 months
radiologic endpoint
- the change in the anatomy of the renal arteries 12 months after renal denervation compared to baseline. for example the existing of renal artery stenosis 12 months after renal denervation compared to baseline: New renal artery stenosis > 60% confirmed by angiogram.
Measured: t=0 and t=12 months
laboratorial endpoint
Absolute changes of: eGFR, plasma renin activity (PRA), aldosterone, ACE, lipid spectrum, proteinuria, insulin, C-peptide, glucose, VMA, metanephrines and catecholamines, 12 months after renal denervation compared to baseline measurements
Measured: t=0 and t=12 months
blood pressure related endpoint
The effect of renal denervation on the development of orthostatic hypotension
- The change in the existing of orthostatic hypotension at baseline compared with the existing at 6 and 12 months after renal denervation will be determined
Measured: t=0 t=6 and t=12 months
blood pressure related endpoint
The change in the effect of blood pressure, renin and aldosterone in the captopril test 12 months after renal denervation compared with the baseline measurements:
Change in blood pressure reaction on captopril. Change in the effect of captopril on absolute changes of aldosterone and renin.
Measured: t=0 and t=12 months
blood pressure related endpoint
The change in home blood pressure measurements during 12 months after renal denervation
Measured: measured every month after renal denervation
endpoint derived from investigations at the vascular laboratory
The in heart rate variability 12 months after renal denervation compared with the baseline measurement
Change in LF/HF-ratio. Change in LF-power.
Measured: t=0 and t=12 months
endpoint derived from investigations at the vascular laboratory
The change of pulse wave velocity 12 months after renal denervation compared with the baseline measurement:
Change in peripheral pressure pulse waveform. Change in central aortic pressure waveform. Change in Augmentation Index (AI).
Measured: t=0 and t=12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, P. J. Blankestijn, UMC Utrecht
- Investigators
- Peter Blankestijn, Dr., Principal investigator, UMC Utrecht department of Nephrology and HypertensionEva Vink, PhD Student, Principal investigator, UMC Utrecht Department of Nephrology and Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427049
- Sponsor's protocol ID
- 11-189
- Other IDs
- NL35945.041.11
- Status last verified
- Jan 2017
- First submitted
- 16 Aug 2011
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blankestijn PJ, Ritz E. Renal denervation: potential impact on hypertension in kidney disease? Nephrol Dial Transplant. 2011 Sep;26(9):2732-4. doi: 10.1093/ndt/gfr190. Epub 2011 Apr 19. No abstract available.
PubMed 21505095Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.
PubMed 21093036Symplicity HTN-1 Investigators. Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension. 2011 May;57(5):911-7. doi: 10.1161/HYPERTENSIONAHA.110.163014. Epub 2011 Mar 14.
PubMed 21403086Siddiqi L, Joles JA, Grassi G, Blankestijn PJ. Is kidney ischemia the central mechanism in parallel activation of the renin and sympathetic system? J Hypertens. 2009 Jul;27(7):1341-9. doi: 10.1097/HJH.0b013e32832b521b.
PubMed 19444143Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28.
PubMed 19332353Verloop WL, Vink EE, Spiering W, Blankestijn PJ, Doevendans PA, Bots ML, Vonken EJ, Voskuil M, Leiner T. Effects of renal denervation on end organ damage in hypertensive patients. Eur J Prev Cardiol. 2015 May;22(5):558-67. doi: 10.1177/2047487314556003. Epub 2014 Oct 17.
PubMed 25326543
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Renal Denervation on Several Biological Variables in Patients With Uncontrolled Hypertension. An Observational Feasibility Study.
- ClinicalTrials.gov ID
- NCT01427049
- Acronym / sponsor ID
- 11-189
- Conditions
- Hypertension
- Keywords
- renal denervation, renal sympathetic denervation, renal ablation, resistant hypertension, hypertension, renal oxygenation, renal perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 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.
Hypertension is a major and growing public health concern. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a major contributor to the complex pathophysiology of (essential) hypertension. The renal sympathetic nerves play a major role in the elevation of the SNS activity. Therapeutic renal denervation (RD), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity - both by reducing the sympathetic modulation of renal function (renin release, sodium excretion and renal blood flow) and by removing the renal afferent sympathetic contribution to central blood pressure elevation.
This current study is an observational exploratory study. The main objective of this study is to learn more on the effects of RD. We wish to do that by quantifying the effects of RD on various biological variables. Those variables are studied in four sets of investigations: a radiological set, a laboratorial set, a set of blood pressure measurements and a set of investigations in the vascular laboratory. The radiological set consists of imaging of the heart and kidney function (renal perfusion) and structure (renal arteries), the laboratorial set of serum and urine tests, 24 h- home- and office- blood pressure measurements will be taken and finally the set of vascular tests contains investigations on pulse wave velocity(PWV) and heart rate variability(HRV). The data will most likely help us to define future studies, to describe the mode of action and the effects of RD on various organs and systems in more detail, and finally to define in more detail which type of hypertensive patients is especially likely to benefit of the procedure.
Hypothesis:
- We hypothesize that LV mass will decrease after RD. Because all patients have severe hypertension, it is likely that a substantial percentage will have increased LV mass.
- We hypothesize that renal perfusion and renal oxygenation increase after RD.
- We hypothesize that there will be no complications related to the device or procedure.
- We hypothesize that renal denervation has a beneficial effect on insulin resistance
- We hypothesize that renal denervation will decrease the blood pressure(office and 24-hour-measurements)
- We hypothesize that RD has a beneficial effect on PWV and HRV.
Detailed description
Objective: The objectives of this study are: the investigation of changes in left ventricular mass (LV mass) after RD using MRI, renal perfusion and renal oxygenation after RD using dynamic contrast enhanced MRI (DCE MRI)and blood oxygenation level dependent MRI (BOLD MRI), the evaluation of safety of RD, in terms of structural changes in the renal arteries and kidney using Magnetic resonance angiography (MRA). Secondly the evaluation of changes in various biological functions assessed by analysis of blood and/or urine samples. Thirdly the quantification of changes in blood pressure. Finally the changes in pulse wave velocity (PWV) and heart rate variability (HRV).
Study design: Observational exploratory-study.
Study population: Adults with a systolic BP ≥160 mmHg (≥150 mmHg for type 2 diabetics) with a stable drug regimen including 3 or more antihypertensive medications, including a diuretic, or inability to follow a stable drug regimen due to unacceptable side-effects of antihypertensive medication.
Main study parameters/endpoints: The effect of RD on: radiological variables: left ventricular wall mass, renal perfusion, renal oxygenation and the anatomy of the renal arteries. Secondly the effect of RD on biological variables assessed by analysis of blood and/or urine samples. Thirdly the changes in blood pressure. Finally the changes in PWV and HRV after RD.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with the tests and procedures performed for the clinical study are limited. There are no known risks associated with MRI when appropriate safety guidelines are followed. Based on the experience form our previous studies, we do not expect any potential risks regarding the cessation of anti-hypertensives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| renal denervation | – | Device: renal denervationAdults with a systolic BP ≥160 mmHg (≥150 mmHg for type 2 diabetics) with a stable drug regimen including 3 or more antihypertensive medications, including a diuretic, or inability to follow a stable drug regimen due to unacceptable side-effects of antihypertensive medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a systolic BP ≥160 mmHg (≥150 mmHg for type 2 diabetics) with a stable drug regimen including 3 or more antihypertensive medications, including a diuretic, or inability to follow a stable drug regimen due to unacceptable side-effects of antihypertensive medication. This current study is an observational exploratory-study.
Key inclusion criteria (5 listed)
- Individual has a systolic BP ≥160 mmHg (≥150 mmHg for type 2 diabetics) based on an average of 3 office BP readings measured according to the guidelines in appendix A.
- Individual is adhering to a stable drug regimen including 3 or more antihypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrolment) which is expected to be maintained for at least 6 months. Or:
- Has experienced side effects to several anti-hypertensive medications
- Individual is ≥18 years of age.
- Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
Key exclusion criteria (26 listed)
- Individual has a treatable secondary cause of hypertension. (it is possible that during baseline procedures secondary causes of hypertension are discovered, those individuals will be excluded from participation of the study.)
- Individual has renal artery anatomy that is ineligible for treatment including:
- Main renal arteries < 4 mm in diameter or < 20 mm in length.
- Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets standards for surgical repair or interventional dilation.
- A history of prior renal artery stenting.
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 Catheter systempercutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system | Device | renal denervation |
Primary outcome
Change in Blood pressure related endpoints:
Time frame: t=0, t=6 and t=12 months
* Incidence of achieving target systolic blood pressure(SBP) (SBP <140 mmHg, or <130 for diabetics) * Incidence of achieving a >10 mmHg reduction in SBP * Change in office BP from baseline to 6 months post-renal denervation. * Change in 24 hour ambulatory blood pressure taken without the use of antihypertensive medication, from baseline to 12 months post-renal denervation. * Changes in SBP and diastolic blood pressure (DBP) from baseline to 6 and 12 months
10 secondary outcomes
Radiologic endpoint
Time frame: t=0 and t=12 months
radiologic endpoint
Time frame: t=0 and t=12 months
radiologic endpoint
Time frame: t=0 and t=12 months
radiologic endpoint
Time frame: t=0 and t=12 months
laboratorial endpoint
Time frame: t=0 and t=12 months
blood pressure related endpoint
Time frame: t=0 t=6 and t=12 months
blood pressure related endpoint
Time frame: t=0 and t=12 months
blood pressure related endpoint
Time frame: measured every month after renal denervation
endpoint derived from investigations at the vascular laboratory
Time frame: t=0 and t=12 months
endpoint derived from investigations at the vascular laboratory
Time frame: t=0 and t=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 2 Feb 2017.
- Background: PubMed 21505095Blankestijn PJ, Ritz E. Renal denervation: potential impact on hypertension in kidney disease? Nephrol Dial Transplant. 2011 Sep;26(9):2732-4. doi: 10.1093/ndt/gfr190. Epub 2011 Apr 19. No abstract available.
- Background: PubMed 21093036Symplicity HTN-2 Investigators; Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Bohm M. Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. Epub 2010 Nov 17.
- Background: PubMed 21403086Symplicity HTN-1 Investigators. Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension. 2011 May;57(5):911-7. doi: 10.1161/HYPERTENSIONAHA.110.163014. Epub 2011 Mar 14.
- Background: PubMed 19444143Siddiqi L, Joles JA, Grassi G, Blankestijn PJ. Is kidney ischemia the central mechanism in parallel activation of the renin and sympathetic system? J Hypertens. 2009 Jul;27(7):1341-9. doi: 10.1097/HJH.0b013e32832b521b.
- Background: PubMed 19332353Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28.
- Derived from this study: PubMed 25326543Verloop WL, Vink EE, Spiering W, Blankestijn PJ, Doevendans PA, Bots ML, Vonken EJ, Voskuil M, Leiner T. Effects of renal denervation on end organ damage in hypertensive patients. Eur J Prev Cardiol. 2015 May;22(5):558-67. doi: 10.1177/2047487314556003. Epub 2014 Oct 17.
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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.
Peter Blankestijn, Dr. principal investigator
UMC Utrecht department of Nephrology and Hypertension
Eva Vink, PhD Student principal investigator
UMC Utrecht Department of Nephrology and Hypertension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by UMC Utrecht at 1 site in Netherlands.
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 26 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 2 Feb 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 Netherlands. 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 Blood pressure related endpoints: (time frame: t=0, t=6 and t=12 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 NCT01427049, which also lists 6 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 2 Feb 2017.