Recruiting
Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)
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.
ClinicalTrials.gov IDNCT06845579
PhaseNA
Enrollment90
SponsorHeart Center Leipzig - University Hospital
Age18 Years
SexALL
Conditions studied
Uncontrolled Arterial Hypertension
About this study
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.
Interventions
- Procedure: 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.
Primary outcomes
- Primary endpoint (target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation))
Eligibility information
Inclusion Criteria:
1. Confirmed arterial hypertension with systolic or diastolic blood pressure \>140/90 mmHg in standardized office blood pressure measurement
2. Treatment with 3 to ≤5 antihypertensive drug classes
3. Age \>18 years
4. Written informed consent
Exclusion Criteria:
1. Age ≤ 18 years
2. anatomy unsuitable for renal denervation (i.e. renal artery stenosis, single functioning kidney)
3. pregnancy
4. patients under legal supervision or guardianship
5. participation in other trials that might interfere with the study outcome according to the opinion of one of the investigators.
Study locations
- Universitätsmedizin Mainz Kardiologie I, Mainz, Rheinland Pflanz 55131 Germany
- Heart Center Leipzig, Leipzig, Saxony 04289 Germany
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.