hypertensie high blood pressure hypertension
Conditions
Interventions
Bilateral renal denervation, using radiofrequency energy delivered to the renal
arterial walls via an intra-arterial catheter.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Individual has an average 24-hour SBP of >= 130 mmHg or a mean day-time SBP >= 135 mmHg, as determined with the use of ABPM, while the patient uses 3 or more antihypertensive agents 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. 2.Individual is >=18 years of age.
Exclusion criteria
Exclusion criteria: 1.Individual has a treatable secondary cause of hypertension 2.Individual has an eGFR below 1. Individual has a treatable secondary cause of hypertension 3.Individual has renal artery anatomy that is ineligible for treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint: change in ABPM (24-h or average day-time 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. | — |
Countries
Netherlands
Outcome results
None listed