To assess the long-term BP lowering effect of renal denervation using a dedicated circumferential ultrasound balloon catheter in patients with resistant hypertension.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in 24h ambulatory systolic BP between baseline and 6 years.
Secondary outcome
Major Adverse Event (MAE) rate (including any of the following elements within
6 years: mortality, embolic events causing end organ damage, renal failure
(eGFR<15 ml/min per 1.73m2 or need for dialysis), new renal artery stenosis of
at least 70%, or hospitalization for hypertensive crisis);
6 year survival status;
change in office systolic and diastolic BP between baseline and 6 years;
change in 24h ambulatory diastolic BP between baseline and 6 years;
change in daytime systolic and diastolic ambulatory BP between baseline and 6
years;
change in nighttime systolic and diastolic ambulatory BP between baseline and 6
years;
change in office and 24h ambulatory BP measurements performed between 1 and 6
years;
change in defined daily dose (DDD) of antihypertensive drugs;
change in eGFR between baseline and 6 years.
Background summary
Hypertension remains a serious risk factor for cardiovascular morbidity and
mortality. Sympathetic overactivity is one of the key contributing factors for
hypertension and several sham controlled randomized controlled trial have
recently shown that renal sympathetic denervation (RDN) using either
radiofrequency energy or circumferential ultrasound has the ability to
significantly lower blood pressure (BP) in hypertensive patients both on- and
off antihypertensive medication up to 6 months. As growing evidence is
available on the short-term efficacy of RDN less is known on its long-term BP
lowering effects in relation to the use of antihypertensive medication.
Study objective
To assess the long-term BP lowering effect of renal denervation using a
dedicated circumferential ultrasound balloon catheter in patients with
resistant hypertension.
Study design
Multicentre, prospective, observational follow-up study.
Study burden and risks
All patients initially enrolled in the ACHIEVE study will be recontacted and
reconsented. Patients will be invited for a single office visit. Non-invasive
study measurements will be a physicial examination, an office BP measurement, a
24h ambulatory BP measurement and a medication review. To determine the
estimated Glomerular Filtration Rate (eGFR) one venapunction per patient will
be performed. Also a retrospective patient file review will be performed to
collect BP and AE data available from earlier outpatient clinic visits.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Initial enrolment in the ACHIEVE-study;
- Treated with the Paradise ultrasound renal denervation system;
- Informed consent;
- The patient agrees to follow-up.
Exclusion criteria
Not applicable.
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 | NL74574.078.20 |