Recruiting NCT06845579
Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Renal sympathetic denervation.
- Who it may be relevant to
- Registry conditions: Uncontrolled Arterial Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Procedure 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.
Primary outcome measures
- 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)]
Secondary outcome measures (3)
- Secondary endpoints [Time frame: months 7 to 9]
- Secondary endpoints [Time frame: one week before renal denervation vs. 6 months after renal denervation]
- Secondary endpoints [Time frame: up to 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 2 centers
- Universitätsmedizin Mainz Kardiologie I — Mainz
- Heart Center Leipzig — Leipzig
Identifiers
NCT: NCT06845579 · 2024-0108