To investigate whether renal denervation leads to a decrease in oxidative stress in patients with therapy-resistant hypertension.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of renal denervation on markers of oxidative stress present in
blood, urine and isolated leukocytes.
Secondary outcome
To determine whether blood pressure, insulin resistance, kidney function and
lipid profile are related to ROS production.
Background summary
Increasing evidence suggests an elevated production of reactive oxygen species
(ROS) in sympathetic hyperactivity states such as hypertension, insulin
resistance, heart failure, chronic kidney disease and obstructive sleep apnea.
In addition, reactive oxygen species can, upon damage or ischemia, activate the
local tissue renin angiotensin system (t-RAS) in a diseased organ that is
innervated by the sympathetic nervous system (SNS). Moreover, both the SNS as
well as RAS are reported to be involved in the pathogenesis of hypertension and
hypertension related diseases. Furthermore, this dual activation could have a
common initiator and several studies suggested ROS could fulfil this role.
Therapeutic renal denervation (PRDN), the deliberate disruption of the nerves
connecting the kidneys with the central nervous system, has been shown to be an
effective means of modulating elevated SNS activity. To discover a correlation
between ROS production and SNS activity in humans, the current study aims to
evaluate the effect of renal sympathetic denervation on the production of ROS
in patients with therapy-resistant hypertension and/or hypertension related
diseases.
Study objective
To investigate whether renal denervation leads to a decrease in oxidative
stress in patients with therapy-resistant hypertension.
Study design
Single centre, prospective, observational study in 30 patients.
Study burden and risks
The minimal risks associated with the measurements described are acceptable.
Based on clinical experience, we do not expect any
potential risks regarding this trial. Possible complications include a
hematoma, (trombo)flebitis or dissection of a vein.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
1. Individual is accepted for treatment with renal denervation as standard therapy for resistant hypertension.
2. Individual is *18 years of age.
3.Individual agrees to have all study procedures performed, and is competent and willing to provide written
informed consent to participate in this clinical study.
Exclusion criteria
1. Individual is excluded from treatment with pRDN.
2. Individual has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2, using the MDRD calculation.
3. Individual is pregnant, nursing or planning to be pregnant.
4. Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46147.041.13 |