Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation

Study Overview
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Brief Summary
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The study is aiming to document the safety and effectiveness of renal denervation in patients after renal transplantation with hypertension. Catheter-based renal denervation will be performed using CE marked, percutaneous Symplicity catheter.

Official Title
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A Randomized Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation in Patients After Renal Transplantation

Conditions
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Hypertension, Chronic Kidney Disease, Renal Transplantation, Sympathetic Activity

Intervention / Treatment
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* Device: Catheter-based renal denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient after renal transplantation (> 6 month) without resection of native kidneys systolic blood pressure >=150 mmHg on 3 or more antihypertensive medications Individual is 18 years of age Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry. Exclusion Criteria: secondary causes and a white coat hypertension renal artery abnormalities eGFR < 30mL/min (MDRD) angina severe Aortic valve stenosis Individual is pregnant, nursing or planning to be pregnant other

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Medical therapy<br>Best medical therapy using guideline recommended drugs in each disease state. | |
| Experimental: Catheter-based renal denervation<br>Renal denervation will be performed in the native renal arteries of patients after renal transplantation. Access side is the contralateral femoral artery. | Device: Catheter-based renal denervation<br> <br> * Other names: Renal denervation with Symplicity Catheter Medtronic/Ardian;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of renal denervation in patients after renal transplantation | Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events. Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound. | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of renal denervation in patients after renal transplantation on different organ systems. | Effects on sympathetic activity assessed by heart rate variability and post extrasystolic potentiation. Glucose metabolism and insulin resistance (fasting and during oGTT). Hospitalization rates (eg. hypertensive emergencies, heart failure, etc). | Baseline to 6 month |