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

Study Overview

• Status: Recruiting
• Conditions: Uncontrolled Arterial Hypertension
• Intervention / Treatment: Procedure: Renal sympathetic denervation

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rheinland Pflanz
    • Mainz, Rheinland Pflanz, Germany, 55131
      • Not yet recruiting
      • Universitätsmedizin Mainz Kardiologie I
      • Contact: Philipp Lurz, Prof. Dr. med.
      • Principal Investigator: Philipp Lurz, Prof. Dr. med.
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Recruiting
      • Heart Center Leipzig
      • Contact: Karl Fengler, Dr. med.; Phone Number: +49341865251197; Email: Karl.Fengler@helios-gesundheit.de
      • Principal Investigator: Karl Fengler, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary endpoints	Time in target range months 7 to 9	months 7 to 9
Secondary endpoints	Change in conventional home blood pressure one week before renal denervation vs. 6 months after renal denervation	one week before renal denervation vs. 6 months after renal denervation
Secondary endpoints	Change in systemic sympathetic activity	up to 12 months

Collaborators and Investigators

• Sponsor: Heart Center Leipzig - University Hospital
• Collaborators: Helios Health Institute GmbH
• Investigators: Principal Investigator: Karl Fengler, Dr. med., Heart Center Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 2024-0108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No