Impact of sympathetic renal denervation : a randomized study in patients after renal transplantation (ISAR-denerve)
© The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved..
BACKGROUND: Sympathetic overactivity is frequently observed following renal transplantation (RTx), and post-transplant hypertension is a major contributing factor to graft failure and cardiovascular morbidity. This process is perpetuated by preservation of sympathetic afferent activity from the native non-functional kidneys, in the absence of efferent feedback to the renal transplant, which would otherwise modulate neurohumoral activity. We investigated the feasibility and efficacy of renal sympathetic denervation (RDN) in renal transplant recipients.
METHODS: Patients (n = 18) with post-transplant hypertension were randomized 1:1 to receive RDN or medical treatment alone. The primary efficacy end point was change in office systolic blood pressure (SBP) and mean 24-h ambulatory blood pressure monitoring (ABPM) at 6 months. Safety end points were changes in renal function or renovascular complications.
RESULTS: After 6 months, patients in the RDN group had a significant reduction in office SBP of 23.3 ± 14.5 mmHg (P = 0.001 for change difference between the groups). In ABPM, nocturnal blood pressure was reduced in the RDN group by -10.38 ± 12.8 mmHg (P = 0.06), whereas no change was measured during the day. In the RDN group, significantly more patients converted from non-dippers to dippers (P = 0.035). There were no adverse safety events in either group.
CONCLUSION: RDN is feasible and safe in renal transplant recipients. However, larger sham-controlled studies will be necessary to clarify the potential role of RDN in this population.
CLINICAL TRIAL REGISTRATION: NCT01899456.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2015 |
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| Erschienen: |
2015 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:30 |
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| Enthalten in: |
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association - 30(2015), 11 vom: 03. Nov., Seite 1928-36 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Schneider, Simon [VerfasserIn] |
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| Links: |
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| Themen: |
Chronic kidney disease |
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| Anmerkungen: |
Date Completed 07.06.2016 Date Revised 16.03.2022 published: Print-Electronic ClinicalTrials.gov: NCT01899456 Citation Status MEDLINE |
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| doi: |
10.1093/ndt/gfv311 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM252400283 |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01899456 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. | ||
| 520 | |a BACKGROUND: Sympathetic overactivity is frequently observed following renal transplantation (RTx), and post-transplant hypertension is a major contributing factor to graft failure and cardiovascular morbidity. This process is perpetuated by preservation of sympathetic afferent activity from the native non-functional kidneys, in the absence of efferent feedback to the renal transplant, which would otherwise modulate neurohumoral activity. We investigated the feasibility and efficacy of renal sympathetic denervation (RDN) in renal transplant recipients | ||
| 520 | |a METHODS: Patients (n = 18) with post-transplant hypertension were randomized 1:1 to receive RDN or medical treatment alone. The primary efficacy end point was change in office systolic blood pressure (SBP) and mean 24-h ambulatory blood pressure monitoring (ABPM) at 6 months. Safety end points were changes in renal function or renovascular complications | ||
| 520 | |a RESULTS: After 6 months, patients in the RDN group had a significant reduction in office SBP of 23.3 ± 14.5 mmHg (P = 0.001 for change difference between the groups). In ABPM, nocturnal blood pressure was reduced in the RDN group by -10.38 ± 12.8 mmHg (P = 0.06), whereas no change was measured during the day. In the RDN group, significantly more patients converted from non-dippers to dippers (P = 0.035). There were no adverse safety events in either group | ||
| 520 | |a CONCLUSION: RDN is feasible and safe in renal transplant recipients. However, larger sham-controlled studies will be necessary to clarify the potential role of RDN in this population | ||
| 520 | |a CLINICAL TRIAL REGISTRATION: NCT01899456 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a chronic kidney disease | |
| 650 | 4 | |a hypertension | |
| 650 | 4 | |a renal sympathetic denervation | |
| 650 | 4 | |a renal transplantation | |
| 700 | 1 | |a Promny, Dominik |e verfasserin |4 aut | |
| 700 | 1 | |a Sinnecker, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a Byrne, Robert A |e verfasserin |4 aut | |
| 700 | 1 | |a Müller, Alexander |e verfasserin |4 aut | |
| 700 | 1 | |a Dommasch, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Wildenauer, Agnes |e verfasserin |4 aut | |
| 700 | 1 | |a Schmidt, Georg |e verfasserin |4 aut | |
| 700 | 1 | |a Heemann, Uwe |e verfasserin |4 aut | |
| 700 | 1 | |a Laugwitz, Karl Ludwig |e verfasserin |4 aut | |
| 700 | 1 | |a Baumann, Marcus |e verfasserin |4 aut | |
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