therapy resistant hypertension in renal transplant recipients
Conditions
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: renal graft in situ since > 6 months, measured creatinine clearance > 35 ml/min, and - diuresis of the native kidneys at transplant >200 ml/day or radiological evidence of residual flow in the renal arteries indicating that they are accessible for the intervention and - day time blood pressure >140/90 mmHg (assessed by 24-hours ambulatory measurement within 3 month prior to inclusion in the study, as is regularly performed in the nephrology outpatient clinic) while - treated according to National Kidney Foundation Kidney Disease Quality Outcomes Quality Initiative guidelines (2004), i.e. having been advised to minimize salt intake and using >3 antihypertensive medications in maximal tolerated dose, including a diuretic or using *4 antihypertensive medications in any dosage. Medications and their dosages should not have been changed since the measurement.
Exclusion criteria
Exclusion criteria: - (planned) pregnancy, lactation - life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is blood pressure reduction after 6 months (day time blood pressure assessed by 24-hours ambulatory measurement). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in 123I-metaiodobenzylguanidine (123I-MIBG) uptake of native kidneys (i.e. effectiveness of denervation) - Change in systemic sympathetic activity and plasma rennin and aldosterone activity - Change in proteinuria after 6 months. - Change in creatinine clearance after 6 months. - Change in eGFR - Change in number of antihypertensive drugs. - Change in health related quality of life.- number of ablation pulses - duration of the intervention - total amount of radio contrast agent (ml) | — |
Countries
Netherlands
Outcome results
None listed