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

NCT ID: NCT06845579

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-02-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Renal sympathetic denervation

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helios Health Institute GmbH

OTHER

Sponsor Role: collaborator

Heart Center Leipzig - University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl Fengler, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig

Locations

Universitätsmedizin Mainz Kardiologie I

Mainz, Rheinland Pflanz, Germany

Site Status: NOT_YET_RECRUITING

Heart Center Leipzig

Leipzig, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Philipp Lurz, Prof. Dr. med.

Role: primary

Karl Fengler, Dr. med.

Role: primary

Karl.Fengler@helios-gesundheit.de

+49341865251197

Other Identifiers

2024-0108

Identifier Type: -

Identifier Source: org_study_id