Prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation.
Confirmed arterial hypertension with systolic or diastolic blood pressure >140/90 mmHg in standardized office blood pressure measurement
Treatment with 3 to ≤5 antihypertensive drug classes
Age >18 years
Written informed consent
Age ≤ 18 years
anatomy unsuitable for renal denervation (i.e. renal artery stenosis, single functioning kidney)
pregnancy
patients under legal supervision or guardianship
Single group
Renal sympathetic denervation
Procedure/SurgeryAll procedures will be carried out by highly experienced interventional cardiologists, each having performed a minimum of 20 RDN prior to treating study patients. All interventions will be performed with the CE-marked Symplicity SpyralTM (Medtronic, Minneapolis, MN, USA) renal denervation system following current treatment standards. Procedures will be performed as stated in the IFU. The specific ablation points will be determined by the discretion of the interventionalist.
Primary endpoint
Difference in time in blood pressure target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
Secondary endpoints
Time in target range months 7 to 9
Secondary endpoints
Change in conventional home blood pressure one week before renal denervation vs. 6 months after renal denervation
Secondary endpoints
Change in systemic sympathetic activity
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Heart Center Leipzig - University Hospital
Lead sponsor
Helios Health Institute GmbH
Collaborator
