Renal denervation to lower blood pressure in hemodialysis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The RDN-HD Study is a prospective, single-center feasibility study aimed at evaluating the safety and efficacy of ultrasound-based renal denervation (RDN) in patients with treatment-resistant hypertension (TRH) undergoing chronic hemodialysis. This study includes patients who have uncontrolled hypertension despite being on multiple antihypertensive medications. The primary goal is to demonstrate that RDN can effectively reduce 24-hour ambulatory blood pressure in this high-risk population. The study does not include a sham group or blinding, focusing solely on the intervention's outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Uncontrolled treatment resistant hypertension (despite intake of 3 different classes of antihypertensive medications) confirmed by 24-h ambulatory blood pressure according to current guidelines (ESH 2023) (office blood pressure ≥ 140/ and/ or ≥ 90 mmHg and ambulatory blood pressure ≥ 130/ and/or ≥ 80 mmHg
* end-stage renal disease on chronic hemodialysis
* Stable hemodialysis regime for at least 3 months based on the decision of the treating physician
* Patient is adhering to a stable drug regimen without changes for a minimum of 4 weeks.
* Individual is ≥ 18 years of age, male and female patients are included.

Exclusion Criteria:

* Episodes of sustained systolic and/or diastolic hypotension according to 24-h ambulatory blood pressure or dialysis protocols which in the eyes of the treating physician would interfere with a safe renal denervation treatment of the patient
* Known hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which in the eyes of the interventionalist would interfere with safe catheter placement
* Prior renal denervation procedure
* Anatomic or functional solitary kidney, kidney transplantation
* Severe atherosclerotic disease or artery calcification preventing the assessment of reliable BP measurements
* Endocrine hypertension other than obstructive sleep apnea
* Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 months of the screening visit
* Acute episode of systemic and renal disease requiring uptitration of any immunosuppressive drug regimen within the last 3 months
* Subject is pregnant, nursing, or intends to become pregnant
* Enrollment in another interventional research protocol.
* Any condition that, at the discretion of the investigator, would preclude participation in the study (e.g. non-adherence)

Where it's running

• Friedrich Alexander University Erlangen Nuremberg, Department of Nephrology and Hypertension
  Erlangen, Bavaria, Germany Recruiting

Study contacts

• Study coordinator: Agnes Bosch, MD
• Email: agnes.bosch@uk-erlangen.de
• Phone: +49 9131 8536207

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.