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

NCT06845579 | Recruiting

• 1 other identifier: 2024-0108
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Uncontrolled Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Secondary endpoints

  months 7 to 9

• Secondary endpoints

  one week before renal denervation vs. 6 months after renal denervation

• Secondary endpoints

  up to 12 months

Study Arms (1)

Renal sympathetic denervation

OTHER

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

Interventions

Renal sympathetic denervation PROCEDURE

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.

Renal sympathetic denervation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Center Leipzig - University Hospital: lead
• Helios Health Institute GmbH: collaborator

Study Sites (2)

Universitätsmedizin Mainz Kardiologie I

Mainz, Rheinland Pflanz, 55131, Germany

NOT YET RECRUITING

Heart Center Leipzig

Leipzig, Saxony, 04289, Germany

RECRUITING

Study Officials

• Karl Fengler, Dr. med.

  Heart Center Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)