RDN for Heart Failure

Официальное название

Efficacy and Safety of Renal Denervation (RDN) for Heart Failure: A Single-Center, Prospective Cohort Study

Обзор

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.

Подробное описание

This is a single-center, prospective, single-arm cohort study to evaluate the efficacy and safety of renal denervation (RDN) using the multi-channel radiofrequency ablation system (Netrod®-RDN System) in patients with symptomatic heart failure (both HFrEF and HFpEF) despite optimal guideline-directed medical therapy.

The study aims to assess whether catheter-based renal sympathetic denervation can improve cardiac function, reduce heart failure biomarkers (NT-proBNP), increase exercise capacity (6MWT), and improve symptoms. Unlike drug trials using a placebo, this study uses a pre-procedure vs. post-procedure comparison design, with no sham/control group.

Technical details of the RDN procedure include: \[The ablation catheter is inserted via the femoral artery and advanced to the renal artery. Ablation is performed at a temperature above 45°C for 120 seconds, starting with the branches followed by the main trunk. After ablation, monoclonal antibody therapy is recommended for 4 weeks\].

Safety will be assessed through monitoring of major adverse events (MAE) within 30 days post-procedure, including vascular complications, renal artery injury, and cardiovascular events, as well as adverse events occurring during the 6-month follow-up period..

Вмешательства

• Устройство Renal denervation
  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 perf

Первичные конечные точки

• Change in NT-proBNP from Baseline to 6 Months [Срок оценки: 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 [Срок оценки: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)]

Вторичные конечные точки (10)

• Change in Left Ventricular Ejection Fraction (LVEF) from Baseline [Срок оценки: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)]
• Change in NT-proBNP at 30 Days and 3 Months [Срок оценки: 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 [Срок оценки: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)]
• Change in New York Heart Association (NYHA) Functional Class [Срок оценки: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)]
• Change in 24-Hour Ambulatory Blood Pressure Monitoring (ABPM) [Срок оценки: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)]
• Change in Office (Clinic) Blood Pressure [Срок оценки: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)]
• Changes in Heart Failure and Antihypertensive Medication Use [Срок оценки: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)]
• Change in Stroke Volume Index (SVI) [Срок оценки: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)]
• Change in Early Diastolic Mitral Inflow Velocity to Early Diastolic Mitral Annular Velocity Ratio (E/e') [Срок оценки: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)]
• Change in Pulmonary Artery Systolic Pressure (PASP) [Срок оценки: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• Severe peripheral vascular disease or abdominal aortic aneurysm.
• Significant (severe) valvular heart disease.
• Persistent or permanent atrial fibrillation; history of ventricular fibrillation or polymorphic ventricular tachycardia; or prior implantation of implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device, or permanent pacemaker.
• Severe hepatic impairment (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], or total bilirubin >3 times the upper limit of normal \[ULN\]).
• Concomitant serious medical conditions that would interfere with study participation or affect survival, such as malignancy or acquired immunodeficiency syndrome (AIDS).
• Acute or severe systemic infection.
• Conditions associated with chronic high-output states, such as severe anemia, advanced liver disease, hyperthyroidism, or arteriovenous fistula.
• Any condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Hospital Fudan University — Шанхай

Идентификаторы

NCT: NCT07558902 · MLWY- HF20250910

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗