Predicting blood pressure response after renal denervation
Official title: Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)
Run by Heart Center Leipzig - University Hospital · NCT06845579 · Data updated 2026-11-12
This study will try renal denervation in adults with uncontrolled high blood pressure on 3–5 medications to see if it lowers day-to-day blood pressure and to build a model that predicts who benefits.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Heart Center Leipzig - University Hospital Academic / other |
| Locations | 2 sites (Mainz, Rheinland Pflanz and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | February 28, 2027 |
| Study ends | February 29, 2028 |
| Registry record updated | June 24, 2025 |
| Trial ID | NCT06845579 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with confirmed uncontrolled arterial hypertension (office BP >140/90 mmHg) who are taking 3 to ≤5 antihypertensive drug classes and have renal artery anatomy suitable for denervation are ideal candidates.
✕Probably not a fit
Patients with unsuitable renal anatomy (for example renal artery stenosis or a single functioning kidney), pregnant individuals, those under legal guardianship, or people whose blood pressure is controlled or who are on fewer than three medications are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
PREDICT-RDN is a prospective, single-arm study applying renal sympathetic denervation to adults with uncontrolled arterial hypertension who are taking multiple antihypertensive drugs. Participants will record day-by-day blood pressure measurements and time spent in a target blood pressure range before and after the procedure. Investigators will combine these longitudinal measurements with clinical and anatomical variables to develop a multivariate prediction model for blood pressure reduction after denervation. Procedures, treatment, and follow-up visits will be conducted at specialized cardiovascular centers in Mainz and Leipzig, Germany.
Why it matters
Potential benefit: If successful, the procedure and prediction model could help identify which patients are most likely to achieve meaningful blood pressure reductions after renal denervation, improving personalized treatment planning.
How similar studies have gone: Recent sham-controlled renal denervation trials have shown modest but reproducible blood pressure reductions, while predictive models for individual response remain an area of active research.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Heart Center Leipzig
Leipzig, Saxony, Germany Recruiting -
Universitätsmedizin Mainz Kardiologie I
Mainz, Rheinland Pflanz, Germany Not yet recruiting
Study contacts
- Principal investigator: Karl Fengler, Dr. med. — Heart Center Leipzig
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.