Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06845579

Prediction of Blood Pressure Outcomes Following Renal Denervation (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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Uncontrolled Arterial Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsmedizin Mainz Kardiologie I, Mainz, Rheinland Pflanz, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Primary endpoint

    Time frame: 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 outcomes

  1. Secondary endpoints

    Time frame: months 7 to 9

    Time in target range months 7 to 9

  2. Secondary endpoints

    Time frame: one week before renal denervation vs. 6 months after renal denervation

    Change in conventional home blood pressure one week before renal denervation vs. 6 months after renal denervation

  3. Secondary endpoints

    Time frame: up to 12 months

    Change in systemic sympathetic activity

Sponsors and collaborators

Lead sponsor

Heart Center Leipzig - University Hospital

Other

Collaborators

  • Helios Health Institute GmbH

Registry information

Acronym: PREDICT-RDN

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 25, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.