Kidney Week

Abstract: FR-OR49

Renal Denervation Is Effective in Reducing Blood Pressure in Patients with CKD: Results of a Multicenter, Prospective, Randomized, Sham-Controlled, Blinded, Investigator-Initiated Trial

Session Information

• Hypertension, CVD, and the Kidneys: Clinical Studies
  October 25, 2024 | Location: Room 5, Convention Center
  Abstract Time: 05:00 PM - 05:10 PM

Category: Hypertension and CVD

• 1602 Hypertension and CVD: Clinical

Authors

• Kannenkeril, Dennis, University Hospital Erlangen, Friedrich- Alexander University Erlangen-Nuremberg (FAU), Erlangen, Germany

Dennis Kannenkeril, MD, MBBS

• Schmieder, Roland E., University Hospital Erlangen, Friedrich- Alexander University Erlangen-Nuremberg (FAU), Erlangen, Germany

Roland E. Schmieder, MD, FASN

• Böhm, Michael, Universitätskliniken des Saarlandes, Saarland University, Homburg, Germany

Michael Böhm, MD

• Mahfoud, Felix, Universitätskliniken des Saarlandes, Saarland University, Homburg, Germany

Felix Mahfoud, MD

• Rump, Lars C., University Hospital, Heinrich-Heine-University, Düsseldorf, Germany

Lars C. Rump, MD

• Stegbauer, Johannes, University Hospital, Heinrich-Heine-University, Düsseldorf, Germany

Johannes Stegbauer, MD

• van der Giet, Markus, Charité – Universitätsmedizin Berlin, Berlin, Germany

Markus van der Giet, DrMed

• Schiffer, Mario, University Hospital Erlangen, Friedrich- Alexander University Erlangen-Nuremberg (FAU), Erlangen, Germany

Mario Schiffer, MD, DrMed, MBA

• Veelken, Roland, University Hospital Erlangen, Friedrich- Alexander University Erlangen-Nuremberg (FAU), Erlangen, Germany

Roland Veelken, MD, DrMed

• Uder, Michael, Institute of Radiology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany

Michael Uder, MD

• Schmid, Axel, Institute of Radiology, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany

Axel Schmid, MD

Background

Arterial hypertension is the predominant driving force of the progression of chronic kidney disease (CKD). The activity of the sympathetic nervous system (SNS) is increased in patients with CKD and endovascular ultrasound renal denervation (uRDN) offers the opportunity to modulate SNS activity and thereby blood pressure and renal outcome.

Methods

In a multicenter prospective randomized sham-controlled clinical trial (clingov:NCT04264403), patients with CKD stage 3 and uncontrolled hypertension despite 1-5 antihypertensive medications were enrolled. Patients were randomly allocated to either uRDN or a sham procedure. The primary endpoint was the change in mean ambulatory systolic BP (ASBP) at 6 months while on stable medication and blinding maintained. Secondary endpoints were changes of other 24h ambulatory BP values, office BP and safety. Due to slow recruitment, the trial was prematurely stopped.

Results

Of 25 randomized patients (mean age 67yrs), 20 subjects had a 6 month visit per protocol. There was no difference in clinical characteristics, pretreatment 24 hour/day/night ambulatory and office BP between the uRDN (N=10) and the sham group (N=10). After 6 months the decrease in 24h (and day) ambulatory diastolic BP (ADBP) was significantly greater in the uRDN compared with sham (p=0.035 (and 0.030)). There was a numerically greater reduction in 24h ASBP in the uRDN group compared to sham, but it did not reach statistical significance. eGFR did not change within 6 months in either group, albuminuria decreased after 3 months in the uRDN group (p=0.023), with significantly greater decrease compared to sham (p=0.029), but this was not found after 6 months. No safety concerns related to uRDN emerged.

Conclusion

In this randomized sham-controlled blinded study, in face of its premature stop leading to a small cohort, we observed a decrease of diastolic BP after uRDN and no safety signals in these hypertensive patients with CKD.

Funding

• Commercial Support – Recor Medical, Inc., Palo Alto, CA, USA