Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis

Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG MEDICAL SCHOOL · Aug 13, 2024

Keywords

ClinConnect Summary

The RDN-HD Study is a clinical trial looking at a new treatment called renal denervation, which uses ultrasound to help lower blood pressure in patients who have high blood pressure that does not respond to standard medications. This study is specifically for adults who are on chronic hemodialysis due to end-stage kidney disease and have been struggling with their blood pressure despite taking three different types of blood pressure medications. To qualify for the study, participants need to be at least 18 years old and have high blood pressure readings both in the doctor's office and over a 24-hour monitoring period.

If someone joins this study, they will receive the ultrasound-based treatment without any placebo or sham procedure, and they will be closely monitored to ensure the treatment is safe and effective. It's important to note that certain conditions may exclude someone from participating, such as having certain heart or kidney problems, recent serious medical events, or being pregnant. Overall, this trial aims to see if this new treatment can help improve blood pressure control in patients who have not had success with other therapies.

Gender

ALL

Eligibility criteria

• 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 ≥ 140/90 mmHg and ambulatory blood pressure ≥ 130/80 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)