RDN for Heart Failure
ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Golden Leaf MedTec Co. Ltd
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Renal denervation
Device1. Procedure: Bilateral renal denervation (RDN) using the multi-channel radiofrequency ablation system. Device Description: The intervention utilizes the Netrod® Multi-Channel Radiofrequency Renal Denervation System, consisting of: (1) a radiofrequency generator (Model 26D1G) with temperature and impedance monitoring capabilities, and (2) a single-use multi-electrode ablation catheter (Model 26C6W127F115T) featuring six spiral-arranged electrodes. 2. Surgical Technique: The procedure is performed percutaneously via femoral artery access under digital subtraction angiography (DSA) guidance. The catheter is advanced to both renal arteries (bilateral treatment). Using the expandable mesh design, the six electrodes contact the arterial wall to deliver radiofrequency energy bilaterally to the main renal arteries, primary branches, and accessible accessory arteries.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Renal Denervation for Heart Failure (RDN-HF)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in NT-proBNP from Baseline to 6 Months
Absolute and relative change in serum N-terminal pro-brain natriuretic peptide (NT-proBNP) levels from baseline (pre-procedure) to 6 months post-renal denervation (RDN) procedure. NT-proBNP is a biomarker of heart failure severity and myocardial wall stress, measured by centralized laboratory assay. The analysis will compare each participant's 6-month NT-proBNP value against their baseline value to determine the magnitude of reduction following RDN treatment.
Time frame
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)2
Change in Six-Minute Walk Test Distance from Baseline to 6 Months
Change in the distance walked (in meters) during the standardized six-minute walk test (6MWT) from baseline to 6 months post-procedure. The 6MWT is conducted according to American Thoracic Society (ATS) guidelines on a flat, hard surface, measuring the total distance walked in 6 minutes. This outcome assesses functional exercise capacity and cardiovascular fitness in heart failure patients. An increase in walking distance indicates improved functional status and exercise tolerance.
Time frame
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)Secondary outcomes
1
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline
Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography.
Time frame
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)2
Change in NT-proBNP at 30 Days and 3 Months
Absolute and relative change in serum N-terminal pro-brain natriuretic peptide (NT-proBNP) levels from baseline to 30 days and 3 months post-procedure.
Time frame
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)3
Change in Six-Minute Walk Test Distance at 30 Days and 3 Months
Change in distance walked (meters) during the standardized six-minute walk test from baseline to 30 days and 3 months post-procedure.
Time frame
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)4
Change in New York Heart Association (NYHA) Functional Class
Change in New York Heart Association (NYHA) Functional Classification (full scale title) assessing symptomatic heart failure status from baseline to each post-procedure visit.Scale details: 4-category ordinal scale, minimum = Class I, maximum = Class IV; higher class = worse cardiac function and more severe heart failure symptoms.
Time frame
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)Sponsors and contacts
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Source ClinicalTrials.gov
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