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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical therapy | No Intervention | Best medical therapy using guideline recommended drugs in each disease state. | |
| Catheter-based renal denervation | Experimental | Renal denervation will be performed in the native renal arteries of patients after renal transplantation. Access side is the contralateral femoral artery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter-based renal denervation | Device |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Schneider, MD | 1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Unversität München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München | Munich | 81675 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26333545 | Result | Schneider S, Promny D, Sinnecker D, Byrne RA, Muller A, Dommasch M, Wildenauer A, Schmidt G, Heemann U, Laugwitz KL, Baumann M. Impact of sympathetic renal denervation: a randomized study in patients after renal transplantation (ISAR-denerve). Nephrol Dial Transplant. 2015 Nov;30(11):1928-36. doi: 10.1093/ndt/gfv311. Epub 2015 Sep 1. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |