Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients with Uncontrolled Hypertension: the RESTART Study

Conditions: high blood pressure
hypertension
10038430
10057166

Registration Number: NL-OMON55957

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1. Age >= 18 years
2. Kidney transplantation >= 12 months ago with stable immunosuppressive drug
treatment (dosage changes to maintain a steady serum concentration are
permitted)
3. Estimated Glomerular Filtration Rate (eGFR) >= 40 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, including a diuretic (defined a thiazide diuretic,
loop diuretic or mineralocorticoid receptor antagonist), for at least three
months, 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

• 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 o Renal artery stenosis > 30% • Presence of a remnant transplant kidney after re-transplantation or absence of native kidneys • Solitary native kidney • 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