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The RDN-HD Study is a prospective, single-center feasibility study. All patients included will undergo endovascular ultrasound-based RDN (no sham group, no blinding). The purpose of the RDN-HD Study is to demonstrate that ultrasound-based RDN is safe in patients with TRH and ESRD hemodialysis and reduces 24-h ambulatory BP.
Patients with end-stage renal disease (ESRD) and hemodialysis have a very high risk for cardiovascular events and a very high cardiovascular mortality. Uncontrolled treatment resistant hypertension (TRH) is an important factor driving this very high cardiovascular event risk. Clinical and experimental studies have clearly shown that sympathetic nerve activity is increased in patients with chronic kidney disease (CKD) and substantially aggravates the progression of CKD. In patients with ESRD and chronic hemodialysis bilateral nephrectomy reduced increased sympathetic nerve activity. Interestingly, kidney transplantation did not normalize peripheral sympathetic activity unless the native kidneys were removed. Thus, afferent sensory nerve signaling from the diseased kidneys to the central nervous system is an important pathophysiologic mechanism in CKD leading to sympathetic overactivity and hypertension. Clinical studies have demonstrated that invasive, catheter-based renal denervation (RDN) decreases the sympathetic nerve activity in the whole body and in particular in the kidneys
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | Intervention: Renal denervation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| renal denervation | Device | ultrasound based renal denervation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints and adverse effects | A major combined safety endpoint is the incidence of any major adverse events (MAE) through the 6 months FU | during 6 months post-procedure |
| Change in 24-h ambulatory systolic blood pressure between baseline and 3 months post-procedure | baseline and 3 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-h ambulatory systolic blood pressure between baseline and 6 months post-procedure | between baseline and 6 months post-procedure. | |
| Change in 24-h ambulatory diastolic blood pressure between baseline and 3, 6 months post-procedure | baseline and 3, 6 months post-procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnes Bosch, MD | Contact | +49 9131 8536207 | agnes.bosch@uk-erlangen.de | |
| Roland E. Schmieder, MD | Contact | +499131 8536207 | roland.schmieder@uk-erlangen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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prospective, single-center feasibility study
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| Change in office (attended) systolic and diastolic blood pressure between baseline and 3, 6 months post-procedure | between baseline and 3, 6 months post-procedure |
| Change in systolic and diastolic home blood pressure between baseline and 3, 6 months post-procedure. | between baseline and 3, 6 months post-procedure |
| Number of antihypertensive drugs, doses, classes at 3, 6 months post-procedure compared to baseline. | at 3, 6 months post-procedure compared to baseline. |
| Change in bio-impedance parameters between baseline and 3, 6 months post-procedure to assess the volume status. | between baseline and 3, 6 months post-procedure |
| Change in central systolic and diastolic blood pressure, central pulse pressure and pulse wave velocity between baseline and 3,6 months post procedure | between baseline and 3,6 months post procedure |
| Change in retinal arteriolar wall to lumen ratio between baseline and 3,6 months post procedure | between baseline and 3,6 months post procedure |
| Change in average daytime/night-time ambulatory systolic blood pressure between baseline and 3, 6 months post-procedure. | between baseline and 3, 6 months post-procedure. |
| Change in average daytime/night-time ambulatory diastolic blood pressure between baseline and 3, 6 months post-procedure | between baseline and 3, 6 months post-procedure |
| Change in office (attended) and ambulatory heart rate between baseline and 3, 6 months post-procedure | between baseline and 3, 6 months post-procedure |
| Changes in dipper/non-dipper patterns between baseline and 3, 6 months post-procedure | between baseline and 3, 6 months post-procedure |
| Change in retinal arterial remodeling between baseline and 3, 6 months post-procedure | between baseline and 3, 6 months post-procedure |
| Change in retinal capillary density between baseline and 3, 6 months post-procedure | between baseline and 3, 6 months post-procedure |