Renal Denervation Hypertension After Stroke

Stroke Clinical Trial

— REHEARSE  

Official title:

Pilot Study in Renal Denervation in Patients With Stroke and Uncontrolled Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01689415
• Other study ID #: H-4-2012-102
• Status: Terminated
• Start date: September 2012
• Est. completion date: November 2014

Study information

• Verified date: January 2021
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Stroke

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Department of neurology	Copenhagen	Region H

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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. — View Citation

Friday G, Alter M, Lai SM. Control of hypertension and risk of stroke recurrence. Stroke. 2002 Nov;33(11):2652-7. — View Citation

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. — View Citation

Kaplan NM. Resistant hypertension. J Hypertens. 2005 Aug;23(8):1441-4. Review. — View Citation

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. — View Citation

Symplicity HTN-2 Investigators, Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Böhm 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour blood pressure		3 months