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ierdenervatie als behandeling van hoge bloeddruk na niertransplantatie.

Suspended
Conditions
Therapy resistant hypertensionrenal allograft recipients
Registration Number
NL-OMON29017
Lead Sponsor
Department of NephrologyAcademic Medical Center at the University of Amsterdam
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Suspended
Sex
Not specified
Target Recruitment
40
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;

Exclusion Criteria

1. (Planned) pregnancy, lactation;

2. Life expectancy < 1 year;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
1. Change in 123I-MIBG uptake of native kidneys (i.e. effectiveness of denervation);<br /><br>2. Change in muscle sympathetic nerve activity, plasma catecholamines, rennin and aldosterone;<br /><br>3. Change in proteinuria after 6 months;<br /><br>4. Change in eGFR after 6 months;<br /><br>5. Change in number of antihypertensive drugs;<br /><br>6. Change in health related quality of life.
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