Impact of sympathetic renal denervation: a randomized study in patients after renal transplantation (ISAR-denerve).
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.


CONCLUSIONS
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.


BACKGROUND
NCT01899456.
I. Medizinische Klinik und Poliklinik, Department of Cardiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Simon
S
Schneider
I. Medizinische Klinik und Poliklinik, Department of Cardiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Dominik
D
Promny
I. Medizinische Klinik und Poliklinik, Department of Cardiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Daniel
D
Sinnecker
Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Robert A
RA
Byrne
I. Medizinische Klinik und Poliklinik, Department of Cardiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Alexander
A
Müller
I. Medizinische Klinik und Poliklinik, Department of Cardiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Michael
M
Dommasch
Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Agnes
A
Wildenauer
I. Medizinische Klinik und Poliklinik, Department of Cardiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany German Centre for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.
Georg
G
Schmidt
Department of Nephrology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Uwe
U
Heemann
I. Medizinische Klinik und Poliklinik, Department of Cardiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany German Centre for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.
Karl Ludwig
KL
Laugwitz
Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Marcus
M
Baumann
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018660:Blood Pressure Monitoring, Ambulatory; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000601:surgery*; D007674:Kidney Diseases / Q000150:complications / Q000601:surgery*; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D012077:Renal Artery / Q000294:innervation* / Q000601:surgery; D013562:Sympathectomy; D016896:Treatment Outcome; D055815:Young Adult
chronic kidney disease; hypertension; renal sympathetic denervation; renal transplantation