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

Heart Center Leipzig - University Hospital

Status: Enrolling

Conditions: Uncontrolled Arterial Hypertension

Treatments: Procedure: Renal sympathetic denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT06845579

2024-0108

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Renal sympathetic denervation

Other group

Description:

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.

Treatment:

Procedure: Renal sympathetic denervation