About this trial
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.
Eligibility criteria
Qualifiers
Aged >18 years and ≤75 years with a clinical diagnosis of heart failure.
Receiving optimized guideline-directed medical therapy (GDMT) for heart failure at stable doses for ≥4 weeks (diuretics stable for ≥2 weeks), with left ventricular ejection fraction (LVEF) ≤40% (HFrEF) or ≥50% (HFpEF).
Symptomatic with exertional dyspnea or chest tightness; New York Heart Association (NYHA) functional class II or III.
Serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level ≥500 pg/mL at screening.
Disqualifiers
Pregnancy or planned pregnancy.
Unsuitable renal artery anatomy for ablation on one or both sides (e.g., renal artery stenosis >50%, renal artery aneurysm, renal artery malformation, renal artery diameter <3 mm, or treatable segment length <20 mm).
Presence of a single kidney, history of renal transplantation, or estimated glomerular filtration rate (eGFR) <40 mL/min/1.73m².
Acute heart failure episode or decompensation within 1 month prior to enrollment.
Trial design
Treatments tested in this trial
- Renal denervation