RecruitingNot ApplicableNCT06845579

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


Sponsor

Heart Center Leipzig - University Hospital

Enrollment

90 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria5

  • Age ≤ 18 years
  • anatomy unsuitable for renal denervation (i.e. renal artery stenosis, single functioning kidney)
  • pregnancy
  • patients under legal supervision or guardianship
  • participation in other trials that might interfere with the study outcome according to the opinion of one of the investigators.

Interventions

PROCEDURERenal 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.


Locations(2)

Universitätsmedizin Mainz Kardiologie I

Mainz, Rheinland Pflanz, Germany

Heart Center Leipzig

Leipzig, Saxony, Germany

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NCT06845579