NCT01689415

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

September 18, 2012

Last Update Submit

January 26, 2021

Conditions

StrokeHypertension

Keywords

Renal nerve denervation

Outcome Measures

Primary Outcomes (1)

  • 24 hour blood pressure

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • + 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital, Department of neurology

Copenhagen, Region H, 2400, Denmark

Location

Related Publications (7)

  • 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.

    PMID: 12411656BACKGROUND

  • 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.

    PMID: 11779934BACKGROUND

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

    PMID: 16003165BACKGROUND

  • 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.

    PMID: 22379110BACKGROUND

  • 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.

    PMID: 21187254BACKGROUND

  • 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.

    PMID: 19332353BACKGROUND

  • 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.

    PMID: 21093036BACKGROUND

MeSH Terms

Conditions

StrokeHypertension

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hanne Christensen, MD,Ph.D,DMSci

    Bispebjerg Hospital - Department of neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Professor, Consultant neurologist

Study Record Dates

First Submitted

September 18, 2012

First Posted

September 21, 2012

Study Start

September 1, 2012

Primary Completion

January 1, 2014

Study Completion

November 1, 2014

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

DK(1)