Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Heart Center Leipzig
RECRUITING
Leipzig
Universitätsmedizin Mainz Kardiologie I
NOT_YET_RECRUITING
Mainz
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 90
Treatments
Other: Renal sympathetic denervation
All 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.
Related Therapeutic Areas
Sponsors
Collaborators: Helios Health Institute GmbH
Leads: Heart Center Leipzig - University Hospital