RDN for Heart Failure

NCT07558902 | Not Yet Recruiting

• 1 other identifier: MLWY- HF20250910
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

RDN(renal denervation) treatment for Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)

• 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.

  Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)

Secondary Outcomes (10)

• Change in Left Ventricular Ejection Fraction (LVEF) from Baseline

  Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)

• Change in NT-proBNP at 30 Days and 3 Months

  Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)

• Change in Six-Minute Walk Test Distance at 30 Days and 3 Months

  Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)

• Change in New York Heart Association (NYHA) Functional Class

  Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)

• Change in 24-Hour Ambulatory Blood Pressure Monitoring (ABPM)

  Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)

Study Arms (1)

Renal Denervation for Heart Failure (RDN-HF)

EXPERIMENTAL

Participants with symptomatic heart failure (NYHA Class II-III) despite optimized medical therapy undergo bilateral renal denervation using the multi-channel radiofrequency ablation system. The study enrolls two phenotypes: Group A and Group B (HFrEF\&HFpEF, LVEF ≤40% or LVEF ≥50%). All participants receive standardized GDMT (SGLT2 inhibitors, beta-blockers, diuretics, ARNI) for ≥4 weeks prior to the procedure. Under DSA guidance, the Netrod® catheter delivers radiofrequency energy (60°C) to bilateral renal arteries including main vessels, branches, and accessory arteries (≥12 points per kidney). Follow-up occurs at 30 days, 3 months, and 6 months to assess NT-proBNP changes, 6-minute walk distance, and safety outcomes.

Device: Renal denervation

Interventions

Renal denervation DEVICE

1. 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.

Renal Denervation for Heart Failure (RDN-HF)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able to provide signed written informed consent personally, or having a legally authorized representative who can provide consent on behalf of the participant.

You may not qualify if:

• 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.
• Office systolic blood pressure (OSBP) ≤100 mmHg or 24-hour mean ambulatory systolic blood pressure (24hASBP) \<90 mmHg.
• Secondary hypertension (e.g., primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid disorders, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).
• History of allergy or hypersensitivity to contrast media.
• History of major surgery or trauma within 3 months prior to enrollment, history of acute coronary syndrome (ACS) within 6 months, or planned surgery or cardiovascular intervention within the next 6 months.
• Symptomatic orthostatic hypotension.
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or dilated cardiomyopathy.
• Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus (HbA1c \>6.5%).
• Primary pulmonary arterial hypertension.
• Significant bleeding diathesis or hematologic disorders (platelet count \<50×10⁹/L, or coagulation abnormalities: activated partial thromboplastin time \[APTT\] or prothrombin time \[PT\] \>3 times upper limit of normal \[ULN\], or international normalized ratio \[INR\] \>1.5).
• History of systemic embolism within 6 months.
• History of stroke or transient ischemic attack (TIA) within 6 months.

Sponsors & Collaborators

• Shanghai Golden Leaf MedTec Co. Ltd: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Chun Li, Bachelor

CONTACT

+86 18205271834; chun.li@brattea.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1\. Single-Arm Design (No Control Group) This study employs a pre-post comparison design without a parallel control or sham procedure group. Each participant serves as their own control, with baseline (pre-procedure) measurements compared against post-procedure outcomes at 30 days, 3 months, and 6 months. This design is appropriate for this pilot, exploratory study aimed at generating preliminary efficacy data and effect size estimates to inform future randomized controlled trials.

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): September 13, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)