high blood pressure
Conditions
Interventions
Conventional angiography and bilateral ultrasound RDN of the native renal
arteries.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years 2. Kidney transplantation >= 9 months ago with stable immunosuppressive drug treatment (dosage changes to maintain a steady serum concentration are permitted) 3. Estimated Glomerular Filtration Rate (eGFR) >= 30 ml/min/1.73m2 4. Office systolic blood pressure >= 140 mmHg at screening (V0), and a systolic mean 24-hour ambulatory blood pressure >= 130 mmHg (V1) 5. With respect to antihypertensive medication: a. Patients should be on a stable regimen of at least two antihypertensive drugs of different classes, for at least six weeks, or b. Patients should have a documented intolerance to three classes of antihypertensive drugs. Patients should only be included when a change in antihypertensive drug regimen is not anticipated within the oncoming three months. 6. Patient is willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: • Native renal artery anatomy not eligible for renale denervatie, defined as at least one of the following conditions: o History of renal artery stenting or angioplasty o History of renal denervation o History of kidney tumors o Renal artery diameter < 3 mm or > 8 mm o Renal artery length < 20 mm o Fibromuscular disease (FMD) of the native renal arteries o Renal artery aneurysm • Presence of a remnant transplant kidney after re-transplantation or absence of native kidneys • History of intravenous contrast dye allergy or nephropathy • Iliac/femoral artery stenosis precluding insertion of the Paradise catheter • Uncorrected, treatable secondary cause of hypertension • Pregnancy • Life expectancy < one year at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in systolic mean 24-hour ambulatory BP between baseline and the 3-months following the RDN procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The most important secondary study outcomes involve: - Composite safety endpoint consisting of the occurrence of any of the following events before the 3-month follow-up visit (F3): all-cause mortality, new onset (acute) end-stage renal disease, significant embolic event resulting in end-organ damage, renal artery perforation requiring an invasive intervention, renal artery dissection requiring an invasive intervention, major vascular complications requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion or hospitalization for hypertensive or hypotensive crisis. - The change in diastolic mean 24-hour ambulatory BP between baseline (V1) and the 3-month follow-up visit (F3) - The change in systolic and diastolic daytime and nighttime ambulatory BP between baseline (V1) and the 3-month follow-up visit (F3) - The change in systolic and diastolic office BP between baseline (V1) and the 3-month follow-up visit (F3) - The change in systolic and diastolic average home BP between baseline (V1) and the 3-month follow-up visit (F3) - The change in systolic and diastolic mean 24-hour, daytime and nighttime ambulatory BP between baseline (V1) and the 3-month follow-up visit (F3) in patients with adherence to the same antihypertensive drugs (as based on serum therapy adherence testing) at both time points - The change in systolic and diastolic office BP between baseline (V1) and the 3-month follow-up visit (F3) in patients with adherence to the same antihypertensive drugs (as based on serum adherence testing) at both time points - The change in systolic and diastolic average home BP between baseline (V1) and the 3-month follow-up visit (F3) in patients with adherence to the same antihypertensive drugs (as based on serum adherence testing) at both time points - The change in prescribed antihypertensive drugs (displayed as the number of DDDs and number of classes) between baseline and 3 months (F3) - The change in th | — |
Countries
Netherlands
Contacts
Public ContactJ. Daemen
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed