Predicting blood pressure response after renal denervation
Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)
NA · Heart Center Leipzig - University Hospital · NCT06845579
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heart Center Leipzig - University Hospital (other) |
| Locations | 2 sites (Mainz, Rheinland Pflanz and 1 other locations) |
| Trial ID | NCT06845579 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mainz, Rheinland Pflanz and 1 other locations
- Universitätsmedizin Mainz Kardiologie I — Mainz, Rheinland Pflanz, Germany (NOT_YET_RECRUITING)
- Heart Center Leipzig — Leipzig, Saxony, Germany (RECRUITING)
Study contacts
- Principal investigator: Karl Fengler, Dr. med. — Heart Center Leipzig
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Uncontrolled Arterial Hypertension