Catheterbased REnal SympatheCtomy for hypErteNsion after kidneyTranplantation
- Conditions
- therapy resistant hypertension in renal transplant recipients1003843010057166
- Registration Number
- NL-OMON39908
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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.
- (planned) pregnancy, lactation - life expectancy < 1 year - non-functioning renal allograft in situ - contraindications for (relative) hypotensive episodes i.e. haemodynamically significant valvular disease, documented transient ischemic attacks or angina pectoris during relative hypotension. - heart failure, NYHA class III-IV; chronic Lung Disease Gold III-IV - major complications during previous radiological interventions (i.e. allergy to contrast agent, cholesterol embolism) - (reno) vascular abnormalities in any part of the catheter access (including the aortic-ileac tract) route that impede the procedure of renal denervation - use of vitamine K antagonists or other (non-aspirin) form of anti-coagulatory therapy with an absolute indication (i.e. that cannot be temporarily stopped) - implantable cardioverter defibrillator (ICD) in situ - planned surgery within the next six months. - Drugs- or alcohol abuse - Inability to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is blood pressure reduction after 6 months (day time blood<br /><br>pressure assessed by 24-hours ambulatory measurement). </p><br>
- Secondary Outcome Measures
Name Time Method <p> - Change in 123I-metaiodobenzylguanidine (123I-MIBG) uptake of native kidneys<br /><br>(i.e. effectiveness of denervation) - Change in systemic sympathetic activity<br /><br>and plasma rennin and aldosterone activity - Change in proteinuria after 6<br /><br>months. - Change in creatinine clearance after 6 months. - Change in eGFR -<br /><br>Change in number of antihypertensive drugs. - Change in health related quality<br /><br>of life.- number of ablation pulses<br /><br>- duration of the intervention - total amount of radio contrast agent (ml)</p><br>