SYMPATHY-NTX study Catheter-based Renal Sympathectomy for Hypertension after Kidney Transplantation - a feasibility study.

Phase 3

Withdrawn

Conditions: therapy resistant hypertension in renal transplant recipients
10038430
10057166

Registration Number: NL-OMON42071

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Age 18-75 years
- First kidney transplant in situ >6 months prior to randomization
- Urine measured creatinine clearance * 30 ml/min
- Radiological evidence for residual flow in the renal arteries indicating that they are accessible for the intervention
- Mean day-time systolic blood pressure of at least 135 mmHg (using ambulatory blood pressure monitoring) despite the use of at least 3 antihypertensive drugs, or with documented intolerance or contraindication for to 2 or more of the 4 major classes of antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics) thus being unable to be treated with 3 antihypertensives.
- Hemodynamically significant stenosis of the renal artery of the graft as a cause of therapy resistant hypertension has to be (have been) excluded (using MRI).

Exclusion Criteria

- (Planned) pregnancy, lactation
- Life expectancy <1 year
- Contraindications for (relative) hypotensive episodes i.e. hemodynamically 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-iliac 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>Main study parameters/endpoints: Primary endpoint is the change in blood<br /><br>pressure after 6 months (mean day time systolic blood pressure assessed by<br /><br>24-hour ambulatory measurement). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include changes in office blood pressure, changes in<br /><br>antihypertensive treatment, plasma catecholamines, renin and aldosterone, eGFR<br /><br>and 24h proteinuria, Moreover, compliance with antihypertensive treatment<br /><br>compliance will be measured using a questionnaire and by detection of<br /><br>antihypertensives in a blood sample. </p><br>