Renal Denervation Hypertension After Stroke | NCT01689415

Studies
Renal Denervation Hypertension After Stroke

NCT01689415

Sponsor

Bispebjerg Hospital

Status

Terminated

Last Update Posted

Jan 28, 2021Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Stroke
Hypertension

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Based on results from SYMPLICITY HTN-3

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Sep 18, 2012

First Submission Date that Met QC Criteria

Sep 18, 2012

First Posted Date

Sep 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2021

Last Update Posted Date

Jan 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hanne Christensen, Associate Research Professor, Consultant neurologist, Bispebjerg HospitalPrincipal Investigator

Lead Sponsor

Bispebjerg HospitalOTHER

Collaborators

Name	Class
Rigshospitalet, Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Measure	Description	Time Frame
24 hour blood pressure		3 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hanne Christensen, MD,Ph.D,DMSci	Bispebjerg Hospital - Department of neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital, Department of neurology		Copenhagen	Region H	2400	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12411656	Background	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.
11779934	Background	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.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases