Catheterbased REnal SympatheCtomy for hypErteNsion after kidneyTranplantation

Completed

Conditions: therapy resistant hypertension in renal allograft recipients
10038430
10038365
10057166

Registration Number: NL-OMON37896

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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. Medications and their dosages should not have been changed since the measurement.

Exclusion Criteria

- (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)<br /><br>- Change in systemic sympathetic activity and plasma rennin and aldosterone<br /><br>activity<br /><br>- Change in proteinuria after 6 months.<br /><br>- Change in creatinine clearance after 6 months.<br /><br>- Change in eGFR<br /><br>- Change in number of antihypertensive drugs.<br /><br>- Change in health related quality of life. </p><br>