Therapy resistant hypertension renal allograft recipients
Conditions
Interventions
Catheter based renal denervation of the native kidneys (Symplicity system, Medtronic). Renal nerve ablation is achieved in a single 40 minute catheterisatioin session.
The control group will receive
Sponsors
Department of Nephrology
Academic Medical Center at the University of Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Renal graft in situ since > 6 months, estimated GFR >35 ml/min/1,73m2 and; 2. Diuresis of the native kidneys at transplant >200 ml/day (to ensure the presence of vital kidney that could be affected by renal nerve ablation) and; 3. 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; 4. 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. Medications and their dosages should not have been changed since the measurement.
Exclusion criteria
Exclusion criteria: 1. (Planned) pregnancy, lactation; 2. Life expectancy < 1 year; 3. Contraindications for (relative) hypotensive episodes i.e. haemodynamically significant valvular disease, documented transient ischaemic attacks or angina pectoris during relative hypotension; 4. Complications during previous radiological interventions (i.e. allergy to contrast agent, cholesterol embolism); 5. (Reno)vascular abnormalities in any part of the catheter access route (including severe femoral or renal artery stenosis and atherosclerosis, previous renal stenting or angioplasty, or known dual renal arteries); 6. Use of vitamine K antagonists or other (non-aspirin) form of anti-coagulatory therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change daytime blood pressure after 6 months after renal denervation assessed by ambulatory blood pressure measurement; compared to continued standard care (i.e. comforming to National Kidney Foundation Kidney Disease Quality Outcomes Quality Initiative guidelines). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in 123I-MIBG uptake of native kidneys (i.e. effectiveness of denervation); 2. Change in muscle sympathetic nerve activity, plasma catecholamines, rennin and aldosterone; 3. Change in proteinuria after 6 months; 4. Change in eGFR after 6 months; 5. Change in number of antihypertensive drugs; 6. Change in health related quality of life. | — |
Contacts
Public ContactC.T.P. Krediet
Department of Nephrology Academic Medical Center at the University of Amsterdam
Outcome results
None listed