Renal Denervation Hypertension After Stroke

Terminated

• Conditions: Stroke; Hypertension

• Registration Number: NCT01689415
• Lead Sponsor: Bispebjerg Hospital

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:

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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Primary Completion: 2014-01
• Study Completion: 2014-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24 hour blood pressure	3 months

Trial Locations

Locations (1)

Bispebjerg Hospital, Department of neurology; 🇩🇰 Copenhagen, Region H, Denmark