Clinical Trial

RDN for Heart Failure

Not Yet Recruiting
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Summary
This is a single-center, prospective, single-arm clinical trial to evaluate the efficacy and safety of renal denervation (RDN) using a multi-channel radiofrequency ablation system in patients with symptomatic heart failure, including both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). The primary objective is to determine whether RDN can reduce serum N-terminal pro-brain natriuretic peptide (NT-proBNP) levels from baseline to 6 months post-procedure, and improve functional exercise capacity as measured by the six-minute walk test (6MWT). Approximately 20 eligible participants will undergo the RDN procedure while continuing their optimal guideline-directed medical therapy for heart failure. Assessments will be performed at baseline (pre-procedure), and at 30 days, 3 months, and 6 months post-procedure. Key evaluations include NT-proBNP measurement, echocardiography, 6MWT, New York Heart Association (NYHA) functional class assessment, and safety monitoring for adverse events. The study aims to provide preliminary clinical evidence on the effects of multi-channel RDN on cardiac biomarkers, functional status, and safety in heart failure patients, and to explore its potential as an adjunctive therapy for this population.
Trial Details
NCT Number NCT07558902
Lead Sponsor Shanghai Golden Leaf MedTec Co. Ltd
Conditions Heart Failure
Enrollment 20 participants
Start Date 2026-05-10
Primary Completion 2027-04-10 (estimated)
Study Completion 2027-09-13 (estimated)
Updated on ClinicalTrials.gov 2026-04-30