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RDN for Heart Failure

27. dubna 2026 aktualizováno: Shanghai Golden Leaf MedTec Co. Ltd

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

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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..

Typ studie

Intervenční

Zápis (Odhadovaný)

20

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Čína, 200030
        • Zhongshan Hospital Fudan University
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. Aged >18 years and ≤75 years with a clinical diagnosis of heart failure.
  2. 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).
  3. Symptomatic with exertional dyspnea or chest tightness; New York Heart Association (NYHA) functional class II or III.
  4. Serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level ≥500 pg/mL at screening.
  5. Able to provide signed written informed consent personally, or having a legally authorized representative who can provide consent on behalf of the participant.

Exclusion Criteria:

  1. Pregnancy or planned pregnancy.
  2. 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).
  3. Presence of a single kidney, history of renal transplantation, or estimated glomerular filtration rate (eGFR) <40 mL/min/1.73m².
  4. Acute heart failure episode or decompensation within 1 month prior to enrollment.
  5. Office systolic blood pressure (OSBP) ≤100 mmHg or 24-hour mean ambulatory systolic blood pressure (24hASBP) <90 mmHg.
  6. Secondary hypertension (e.g., primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid disorders, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).
  7. History of allergy or hypersensitivity to contrast media.
  8. 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.
  9. Symptomatic orthostatic hypotension.
  10. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or dilated cardiomyopathy.
  11. Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus (HbA1c >6.5%).
  12. Primary pulmonary arterial hypertension.
  13. 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).
  14. History of systemic embolism within 6 months.
  15. History of stroke or transient ischemic attack (TIA) within 6 months.
  16. Severe peripheral vascular disease or abdominal aortic aneurysm.
  17. Significant (severe) valvular heart disease.
  18. 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.
  19. Severe hepatic impairment (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or total bilirubin >3 times the upper limit of normal [ULN]).
  20. Concomitant serious medical conditions that would interfere with study participation or affect survival, such as malignancy or acquired immunodeficiency syndrome (AIDS).
  21. Acute or severe systemic infection.
  22. Conditions associated with chronic high-output states, such as severe anemia, advanced liver disease, hyperthyroidism, or arteriovenous fistula.
  23. Any condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Renal Denervation for Heart Failure (RDN-HF)
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.
Přístroj: 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 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in NT-proBNP from Baseline to 6 Months
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography.
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in NT-proBNP at 30 Days and 3 Months
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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.
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
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in distance walked (meters) during the standardized six-minute walk test from baseline to 30 days and 3 months post-procedure.
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in New York Heart Association (NYHA) Functional Class
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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.
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in 24-Hour Ambulatory Blood Pressure Monitoring (ABPM)
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Changes in 24-hour average systolic and diastolic blood pressure, including daytime and nighttime blood pressure values.
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in Office (Clinic) Blood Pressure
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Changes in sitting systolic and diastolic blood pressure measured in the clinic setting at each follow-up visit.
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Changes in Heart Failure and Antihypertensive Medication Use
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Documentation of changes in dose, frequency, or type of guideline-directed medical therapy (GDMT) including SGLT2 inhibitors, beta-blockers, diuretics, ARNI/ACE inhibitors, and other antihypertensive agents.
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in Stroke Volume Index (SVI)
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Stroke volume index (SVI) = Stroke volume / Body surface area (m 2), assessed by transthoracic echocardiography.
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')
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
E/e' ratio assessed by transthoracic echocardiography.
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in Pulmonary Artery Systolic Pressure (PASP)
Časové okno: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Pulmonary artery systolic pressure (PASP) assessed by transthoracic echocardiography.
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Shanghai Golden Leaf MedTec Co. Ltd

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

10. května 2026

Primární dokončení (Odhadovaný)

10. dubna 2027

Dokončení studie (Odhadovaný)

13. září 2027

Termíny zápisu do studia

První předloženo

27. února 2026

První předloženo, které splnilo kritéria kontroly kvality

27. dubna 2026

První zveřejněno (Aktuální)

30. dubna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. dubna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. dubna 2026

Naposledy ověřeno

1. února 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MLWY- HF20250910

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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