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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06845579

Acronym

PREDICT-RDN

Enrollment

Registered

2025-02-25

Start date

2025-06-01

Completion date

2028-02-29

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncontrolled Arterial Hypertension

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.

Interventions

PROCEDURERenal 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Secondary endpoints	months 7 to 9	Time in target range months 7 to 9

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026