Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Primary endpoint — target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
  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)

Trial sites (2)

More Heart Center Leipzig - University Hospital trials in Germany