StrokeREHEARSENCT01689415
Renal Denervation Hypertension After Stroke
An observational study of Stroke and Hypertension, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
It is known, that hypertension is the major risk factor of stroke and recurrent stroke. Blood pressure reduction - together with antithrombotics - remain crucial in stroke prevention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hypertension
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Nov 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: Patients in the study population must be 18+ years old and have a clinical verified stroke within the last year and treatment resistant hypertension at 150 mm Hg or higher systolic at consultation. The patients Modified Ranking Scale must be between 0-2.
Who may be able to join
- 18+ years old
- Clinical verified stroke within the last year
- Treatment resistant hypertension at 150 mm Hg or higher systolic at consultation
- Modified Ranking between 0-2
Who cannot join
- Lack of informed consent
- Renal artery anatomy, which prevents the procedure
- Reno vascular disease
- Pacemaker
- Haemodynamic vascular occlusion or valve disease
- Pregnancy or women in the childbearing age
- Secondary hypertension
- Mean systolic blood pressure over 180 mm Hg
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, Department of neurology
Copenhagen, Region H, 2400
About this study
Official title: Pilot Study in Renal Denervation in Patients With Stroke and Uncontrolled Hypertension
It is known, that hypertension is the major risk factor of stroke and recurrent stroke. Blood pressure reduction - together with antithrombotics - remain crucial in stroke prevention.
This pilot study will examine the effect of renal nerve denervation in patients with treatment resistant hypertension after ischemic stroke or DWI/DTI-verified stroke. With 24 hours blood pressure measurements the effect after renal nerve denervation is examined 1,3,6 and 12 months after the procedure.
Read the detailed description
Radio frequent ablation is used to renal nerve denervation (RND) and is a new invasive method used in treatment for hypertensive patients, where the sympathetic nerves to the kidneys ablates. RND shows a significant reduction in the systolic and diastolic blood pressure in patients with treatment resistant hypertension.
The hypothesis is that RDN is able to reduce the blood pressure in patients with previous stroke and treatment resistant hypertension and thereby reduce the risk of a new stroke.
Aim of study:
- To validate the reduction in blood pressure after RND in patients with stroke and treatment resistant hypertension compared to the results achieved in patients only with essential hypertension
- To examine if this treatment is possible on patients after stroke (procedure related limitations and security of the patient)
- To describe the effect of RND in the development of changes in the white matter over time
- Conditions
- Stroke, Hypertension
- Keywords
- Renal nerve denervation
- Medical subject headings
- Stroke, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour blood pressure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionNov 2014
Why it stopped: Based on results from SYMPLICITY HTN-3
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Hanne Christensen, Bispebjerg Hospital
- Investigators
- Hanne Christensen, MD,Ph.D,DMSci, Principal investigator, Bispebjerg Hospital - Department of neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689415
- Sponsor's protocol ID
- H-4-2012-102
- Acronym
- REHEARSE
- Status last verified
- Jan 2021
- First submitted
- 18 Sep 2012
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Friday G, Alter M, Lai SM. Control of hypertension and risk of stroke recurrence. Stroke. 2002 Nov;33(11):2652-7. doi: 10.1161/01.str.0000033929.62136.6f.
PubMed 12411656van Gijn J. The PROGRESS Trial: preventing strokes by lowering blood pressure in patients with cerebral ischemia. Emerging therapies: critique of an important advance. Stroke. 2002 Jan;33(1):319-20. No abstract available.
PubMed 11779934Kaplan NM. Resistant hypertension. J Hypertens. 2005 Aug;23(8):1441-4. doi: 10.1097/01.hjh.0000174968.72212.ac.
PubMed 16003165Daugherty SL, Powers JD, Magid DJ, Tavel HM, Masoudi FA, Margolis KL, O'Connor PJ, Selby JV, Ho PM. Incidence and prognosis of resistant hypertension in hypertensive patients. Circulation. 2012 Apr 3;125(13):1635-42. doi: 10.1161/CIRCULATIONAHA.111.068064. Epub 2012 Feb 29.
PubMed 22379110Hornnes N, Larsen K, Boysen G. Blood pressure 1 year after stroke: the need to optimize secondary prevention. J Stroke Cerebrovasc Dis. 2011 Jan-Feb;20(1):16-23. doi: 10.1016/j.jstrokecerebrovasdis.2009.10.002. Epub 2010 Jun 17.
PubMed 21187254Krum 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 19332353Symplicity 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 21093036
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study in Renal Denervation in Patients With Stroke and Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT01689415
- Acronym / sponsor ID
- REHEARSE / H-4-2012-102
- Conditions
- Stroke, Hypertension
- Keywords
- Renal nerve denervation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Based on results from SYMPLICITY HTN-3
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Sep 2012 (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.
It is known, that hypertension is the major risk factor of stroke and recurrent stroke. Blood pressure reduction - together with antithrombotics - remain crucial in stroke prevention.
This pilot study will examine the effect of renal nerve denervation in patients with treatment resistant hypertension after ischemic stroke or DWI/DTI-verified stroke. With 24 hours blood pressure measurements the effect after renal nerve denervation is examined 1,3,6 and 12 months after the procedure.
Detailed description
Radio frequent ablation is used to renal nerve denervation (RND) and is a new invasive method used in treatment for hypertensive patients, where the sympathetic nerves to the kidneys ablates. RND shows a significant reduction in the systolic and diastolic blood pressure in patients with treatment resistant hypertension.
The hypothesis is that RDN is able to reduce the blood pressure in patients with previous stroke and treatment resistant hypertension and thereby reduce the risk of a new stroke.
Aim of study:
- To validate the reduction in blood pressure after RND in patients with stroke and treatment resistant hypertension compared to the results achieved in patients only with essential hypertension
- To examine if this treatment is possible on patients after stroke (procedure related limitations and security of the patient)
- To describe the effect of RND in the development of changes in the white matter over time
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the study population must be 18+ years old and have a clinical verified stroke within the last year and treatment resistant hypertension at 150 mm Hg or higher systolic at consultation. The patients Modified Ranking Scale must be between 0-2.
Key inclusion criteria (4 listed)
- 18+ years old
- Clinical verified stroke within the last year
- Treatment resistant hypertension at 150 mm Hg or higher systolic at consultation
- Modified Ranking between 0-2
Key exclusion criteria (8 listed)
- Lack of informed consent
- Renal artery anatomy, which prevents the procedure
- Reno vascular disease
- Pacemaker
- Haemodynamic vascular occlusion or valve disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
24 hour blood pressure
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Based on results from SYMPLICITY HTN-3). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Background: PubMed 12411656Friday G, Alter M, Lai SM. Control of hypertension and risk of stroke recurrence. Stroke. 2002 Nov;33(11):2652-7. doi: 10.1161/01.str.0000033929.62136.6f.
- Background: PubMed 11779934van Gijn J. The PROGRESS Trial: preventing strokes by lowering blood pressure in patients with cerebral ischemia. Emerging therapies: critique of an important advance. Stroke. 2002 Jan;33(1):319-20. No abstract available.
- Background: PubMed 16003165Kaplan NM. Resistant hypertension. J Hypertens. 2005 Aug;23(8):1441-4. doi: 10.1097/01.hjh.0000174968.72212.ac.
- Background: PubMed 22379110Daugherty SL, Powers JD, Magid DJ, Tavel HM, Masoudi FA, Margolis KL, O'Connor PJ, Selby JV, Ho PM. Incidence and prognosis of resistant hypertension in hypertensive patients. Circulation. 2012 Apr 3;125(13):1635-42. doi: 10.1161/CIRCULATIONAHA.111.068064. Epub 2012 Feb 29.
- Background: PubMed 21187254Hornnes N, Larsen K, Boysen G. Blood pressure 1 year after stroke: the need to optimize secondary prevention. J Stroke Cerebrovasc Dis. 2011 Jan-Feb;20(1):16-23. doi: 10.1016/j.jstrokecerebrovasdis.2009.10.002. Epub 2010 Jun 17.
- 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.
- 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.
Related trials for Stroke
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit
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.
Hanne Christensen, MD,Ph.D,DMSci principal investigator
Bispebjerg Hospital - Department of neurology
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 Stroke and Hypertension, run by Bispebjerg Hospital at 1 site in Denmark.
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 4 inclusion and 8 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 28 Jan 2021. 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 Denmark. 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 was stopped early (reason given: Based on results from SYMPLICITY HTN-3). 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?
24 hour blood pressure (time frame: 3 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 NCT01689415, which also lists 7 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 28 Jan 2021.