The primary objective is to assess whether renal denervation added to usual care compared to usual care alone reduces BP (office based BP and 24-h ambulatory BP-monitoring) both in subjects with a SBP level above 160 mmHg as well as subjects with a…
ID
Source
Brief title
Condition
- Other condition
- Renal disorders (excl nephropathies)
Synonym
Health condition
hoge bloeddruk
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary effectiveness endpoint is change in office BP at six months
follow-up.
Secondary outcome
Secondary study parameters/endpoints: Incidence of achieving target BP (SBP
<140 mmHg, or <130 for diabetics), incidence of achieving a >10 mmHg reduction
in SBP, change in 24 hour ambulatory BP, change in eGFR, change in
proteinuria/albuminuria, change in Quality of life, health care costs,
non-healthcare costs and costs per Quality Adjusted Life Year.
Background summary
Hypertension is a major and growing public health concern. Chronic elevation of
sympathetic nervous system (SNS) activity has been identified as a major
contributor to the complex pathophysiology of (essential) hypertension. The
renal sympathetic nerves play a major role in the elevation of the SNS
activity. Therapeutic renal denervation (RD), the deliberate disruption of the
nerves connecting the kidneys with the central nervous system, has been shown
to effective and safe in patients with hypertension (SBP>160 mmHg) resistant to
hypertension. The effect of RD in patients with less severe hypertension and
patients with chronic kidney disease (CKD) stage 3 to 5 is not investigated
yet. We hypothesize that renal denervation also has beneficial effects in these
patients.
RD is relatively expensive compared to pharmaceutical treatment. Therefore, it
is important to perform an economic evaluation. We expect that the initial
investments in RD may be counterbalanced by the fact that savings on direct
health care costs are possible after some years, as lifelong use of multiple
antihypertensive drugs will possibly be reduced or become unnecessary.
Study objective
The primary objective is to assess whether renal denervation added to usual
care compared to usual care alone reduces BP (office based BP and 24-h
ambulatory BP-monitoring) both in subjects with a SBP level above 160 mmHg as
well as subjects with a SBP level between 140 and 160 mmHg, despite the use of
three or more BP lowering drugs.
Secondary objectives are: 1) To study whether the effect of RD is similar
across strata of eGFR. 2) To assess the effects renal denervation on BP
lowering drug use. 3) To identify factors that relate to a beneficial response
to RD (responders). 4) To study the cost-effectiveness of RD in comparison with
usual care for hypertensive patients.
Study design
The trial will start enrolling patients with SBP of 140 mmHg or above (and
three or more BP lowering drugs). When 3 months follow-up data on systolic BP
are available for 60 patients in the group with SBP between 140 and 160 mmHg,
treatment arms will be compared with respect to change in systolic arterial
pressure at 3 months. In case the estimated difference in decrease of SBP is
less or equal to 0 (i.e., no beneficial trend for renal denervation),
recruitment for this group will terminate and only patients with SBP >= 160 mmHg
will continue to be recruited up to their original total of 130.
Intervention
The intervention group will, additional to usual care, be treated with RD.
Usual care is determined as therapy of hypertension in line with cardiovascular
disease prevention guidelines. The control group will be treated according to
usual care.
Study burden and risks
Published studies have reported an excellent safety profile of RD. Procedure
related complications have been few in number and of the type expected for an
endovascular procedure utilizing femoral arterial access. Most of the
complications consisted of groin complications and a single renal artery
dissection that occurred prior to delivery of RF energy by the RD catheter.
These events were treated with standard measures and all resolved without
sequelae. Long term vascular safety has been demonstrated by follow-up imaging
studies which showed no lesion formation at any of the RF energy treatment
sites examined. The safety profile of RD is expected to be the same for
patients with a lower BP (BP >=140mmHg).
Heidelberglaan 100 F03.223
Utrecht 3584 CX
NL
Heidelberglaan 100 F03.223
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1.Individual has a mean daytime SBP >= 135 mmHg determined with the use of 24-h or daytime ambulatory BP monitoring while the individual uses antihypertensives.
2.Individual uses at least 3 antihypertensive drugs.
3.Individual is >=18 years of age.
Exclusion criteria
1. Individual is unable or unwilling to sign informed consent
2. Individual has a treatable secondary cause of hypertension
3. Individual has an eGFR below 20mL/min/1.73m2 using the MDRD calculation
4. Individual has renal artery anatomy that is ineligible for treatment
5. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study
6. Individual is pregnant, nursing or planning to be pregnant.
7. 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.
8. Individual is currently enrolled in another investigational drug or device trial.
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 | NL39726.041.12 |