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Active Not Recruiting NCT07742787

Renal Denervation in Chronic Kidney Disease - RDN-CKD Study (RDN-CKD GR)

Conditions: Uncontrolled Hypertension, Renal Denervation, Chronic Kidney Disease (Stage 3)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Hippocration General Hospital

Location: Hippocratio General Hospital Athens

Summary

RDN-CKD GR Study is a prospective, randomized (1:1), double-blind (unblinded interventionalist and blinded study team), sham controlled study. The purpose of the RDN-CKD GR Study is to demonstrate that renal denervation (RDN) effectively reduces 24-h ambulatory BP in 20 patients with chronic kidney disease (CKD) stage 3a or 3b.

Eligibility Criteria

Inclusion Criteria: * CKD stage 3 (eGFR 30-59 ml/min/1.73m² \[according to the currently used estimation formulas: MDRD, CKD-EPI\]) with diabetic or non-diabetic nephropathy * Uncontrolled hypertension with 1-5 drug classes (renin angiotensin system \[RAS\] blockade is mandatory, unless intolerance to RAS blockers has been documented) and systolic office (attended) BP ≥140 mmHg confirmed by 24-h ambulatory BP systolic ≥130 mmHg * Patient is adhering to a stable drug regimen including RAS blockade without changes for a minimum of 4 weeks. * Individual is ≥ 18 years of age, both genders are included Exclusion Criteria: * Anatomically significant renal artery abnormality in either renal artery which in the eyes of the interventionalist would interfere with safe catheter Placement * Other cause of Hypertension that can be treated by Intervention/surgery (e.g. hemodynamically relevant renal artery stenosis, functional adrenal adenoma) * Prior renal denervation procedure * Office (attended) BP ≥ 180 mmHg systolic and/or ≥ 110 mmHg diastolic * 24-h ambulatory BP ≥ 160 mmHg systolic * Anatomic or functional solitary kidney, kidney transplantation * Lack of capturing serum creatinine levels in the past * Secondary hypertension other than obstructive sleep apnea * Type 1 diabetes mellitus * Nephrotic syndrome * Contraindication to magnetic resonance imaging (MRI) * Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 months of the screening visit * Acute episode of 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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07742787). StuddyBuddy aggregates publicly available trial information.