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RDN for Heart Failure

27. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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..

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in NT-proBNP from Baseline to 6 Months
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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')
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shanghai Golden Leaf MedTec Co. Ltd

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

10. Mai 2026

Primärer Abschluss (Geschätzt)

10. April 2027

Studienabschluss (Geschätzt)

13. September 2027

Studienanmeldedaten

Zuerst eingereicht

27. Februar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. April 2026

Zuerst gepostet (Tatsächlich)

30. April 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. April 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. April 2026

Zuletzt verifiziert

1. Februar 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MLWY- HF20250910

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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