hypertensie high blood pressure hypertension
Conditions
Interventions
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
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The endpoints are conform the endpoints formulated in the Sympathy study: change in ABPM (average daytime SBP). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed