Renal Denervation Hypertension After Stroke

NCT ID: NCT01689415

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-11-30

Brief Summary

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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

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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:

1. 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
2. To examine if this treatment is possible on patients after stroke (procedure related limitations and security of the patient)
3. To describe the effect of RND in the development of changes in the white matter over time

Conditions

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Stroke Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hanne Christensen

Associate Research Professor, Consultant neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanne Christensen, MD,Ph.D,DMSci

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital - Department of neurology

Locations

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Bispebjerg Hospital, Department of neurology

Copenhagen, Region H, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 12411656 (View on PubMed)

van 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.

Reference Type BACKGROUND
PMID: 11779934 (View on PubMed)

Kaplan NM. Resistant hypertension. J Hypertens. 2005 Aug;23(8):1441-4. doi: 10.1097/01.hjh.0000174968.72212.ac.

Reference Type BACKGROUND
PMID: 16003165 (View on PubMed)

Daugherty 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.

Reference Type BACKGROUND
PMID: 22379110 (View on PubMed)

Hornnes 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.

Reference Type BACKGROUND
PMID: 21187254 (View on PubMed)

Krum 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.

Reference Type BACKGROUND
PMID: 19332353 (View on PubMed)

Symplicity 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.

Reference Type BACKGROUND
PMID: 21093036 (View on PubMed)

Other Identifiers

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H-4-2012-102

Identifier Type: -

Identifier Source: org_study_id

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