The primary objective is to assess whether RDN by other devices than Medtronic added to usual care compared to usual care alone reduces BP in subjects, classified as non-responders on renal denervation, six months after RDN.
ID
Source
Brief title
Condition
- Other condition
- Renal disorders (excl nephropathies)
Synonym
Health condition
hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The endpoints are conform the endpoints formulated in the Sympathy study:
change in ABPM (average daytime SBP).
Secondary outcome
Key secondary study parameters/endpoints: 1) Change in the amount of
antihypertensive medication (daily defined dose). 2) The effect of RD in
subgroups: across strata of eGFR (eGFR 20-60 mL/min per 1.73m2 and eGFR>60
mL/min per 1.73m2) and across strata of baseline BP (SBP 140-160mmHg and
>160mmHg). 3) Change in office BP.
Further, information will be collected concerning :
* The effect of RDN on renal function and the incidence of peri-procedural
complications
* The long term effect of RDN on fatal- and non-fatal cardiovascular events
* Cost-effectiveness of the procedure,
* Impact of RDN on quality of life
* Budget impact analyses
* Explorative analysis will be done of predictors of effect and of mechanisms
of the BP-lowering effect.
Background summary
Hypertension is a major and growing problem worldwide. Overactivity of the
sympathetic nervous system is identified as a major cause in the development of
hypertension. The sympathetic renal nerves play an important role in the
process of increased sympathetic activity. Studies have shown that renal
denervation, the disruption of the nerves that connect the kidneys to the
central nervous system, is an effective and safe treatment for patients with
resistant hypertension (systolic blood pressure of at least 140 mm Hg) despite
the use of at least 3 antihypertensive agents. However, there are two groups
that that we can differentiate: 1), the group which has a clear effect of the
treatment, and 2) a group that has little or no effect of the treatment. At
present, on the basis of new insights, the medical devices are adjusted.
Studies with this new and improved device show a promising fall in blood
pressure in patients with elevated blood pressure. Also in the group of
patients who have been previously treated with the Symplicity catheter of
Medtronic (first generation catheter), renal denervation again with a new and
improved catheter (second generation catheter), lowered blood pressure.
Study objective
The primary objective is to assess whether RDN by other devices than Medtronic
added to usual care compared to usual care alone reduces BP in subjects,
classified as non-responders on renal denervation, six months after RDN.
Study design
This study is a pilot study. The study design is equal to the Sympathy study
(METC-number 12-540), a randomized controlled trial, therefore baseline and
follow-up visits are according Sympathy protocol.
Intervention
The intervention group will, additional to usual care, be treated with RDN.
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 RDN.
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.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1.Individual is *18 years of age.
2. Individual has a mean day-time SBP * 135 mmHg, as determined with the use of ABPM, while the patient uses 3 or more antihypertensive agents for at least 3 months prior to inclusion or with documented intolerance to 2 or more of the 4 major classes antihypertensive drugs (ACE/ARB, Calcium channel blocker, Beta Blocker, Diuretic) and no possibility to take 3 anti-hypertensive drugs.
3. Individual has been treated with renal denervation as treatment for hypertension * 12 months prior for inclusion.
4. Individual has been treated with renal denervation, performed with the Symplicity Flex catheter.
5. Individual has a decrease in systolic ABPM < 10 mmHg compared to baseline.;The inclusion criteria are the same as for the Sympathy study, plus the addition of the last three criteria.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:;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 20 mL/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 participates (participated) in the Sympathy study.;The exclusion criteria are the same as for the Sympathy study plus the last criteria.
Design
Recruitment
Medical products/devices used
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 | NL54632.041.15 |