[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635916":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":46,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":20,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":69,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Shanghai Golden Leaf MedTec Co. Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: Renal denervation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Renal denervation","1. Procedure: Bilateral renal denervation (RDN) using the multi-channel radiofrequency ablation system.\n\n   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.\n2. 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.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Chun Li, Bachelor","CONTACT","+86 18205271834","chun.li@brattea.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Zhongshan Hospital Fudan University","Shanghai","Shanghai Municipality","200030","China","CN",{"type":36,"coordinates":37},"Point",[38,39],121.45806,31.22222,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":45},"Zhifeng Yao, Doctor","+86 18616881272","zhifengyao@126.com",{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100635916","rdn-for-heart-failure-100635916",false,"NCT07558902","RDN for Heart Failure","Efficacy and Safety of Renal Denervation (RDN) for Heart Failure: A Single-Center, Prospective Cohort Study","Inclusion Criteria:\n\n1. Aged \\>18 years and ≤75 years with a clinical diagnosis of heart failure.\n2. 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).\n3. Symptomatic with exertional dyspnea or chest tightness; New York Heart Association (NYHA) functional class II or III.\n4. Serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level ≥500 pg\u002FmL at screening.\n5. Able to provide signed written informed consent personally, or having a legally authorized representative who can provide consent on behalf of the participant.\n\nExclusion Criteria:\n\n1. Pregnancy or planned pregnancy.\n2. 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 \\\u003C3 mm, or treatable segment length \\\u003C20 mm).\n3. Presence of a single kidney, history of renal transplantation, or estimated glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73m².\n4. Acute heart failure episode or decompensation within 1 month prior to enrollment.\n5. Office systolic blood pressure (OSBP) ≤100 mmHg or 24-hour mean ambulatory systolic blood pressure (24hASBP) \\\u003C90 mmHg.\n6. Secondary hypertension (e.g., primary aldosteronism, pheochromocytoma\u002Fparaganglioma, Cushing's syndrome, thyroid disorders, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).\n7. History of allergy or hypersensitivity to contrast media.\n8. 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.\n9. Symptomatic orthostatic hypotension.\n10. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or dilated cardiomyopathy.\n11. Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus (HbA1c \\>6.5%).\n12. Primary pulmonary arterial hypertension.\n13. Significant bleeding diathesis or hematologic disorders (platelet count \\\u003C50×10⁹\u002FL, 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).\n14. History of systemic embolism within 6 months.\n15. History of stroke or transient ischemic attack (TIA) within 6 months.\n16. Severe peripheral vascular disease or abdominal aortic aneurysm.\n17. Significant (severe) valvular heart disease.\n18. 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.\n19. Severe hepatic impairment (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], or total bilirubin \\>3 times the upper limit of normal \\[ULN\\]).\n20. Concomitant serious medical conditions that would interfere with study participation or affect survival, such as malignancy or acquired immunodeficiency syndrome (AIDS).\n21. Acute or severe systemic infection.\n22. Conditions associated with chronic high-output states, such as severe anemia, advanced liver disease, hyperthyroidism, or arteriovenous fistula.\n23. Any condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":59,"type":60},20,"ESTIMATED","INTERVENTIONAL",[63],"NA","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).\n\nApproximately 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.\n\nThe 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.",[66],"Heart Failure",[68],"RDN(renal denervation) treatment for Heart Failure","NOT_YET_RECRUITING","2026-04-27",{"date":72,"type":73},"2026-04-30","ACTUAL",{"date":75,"type":60},"2026-05-10",{"date":77,"type":60},"2027-09-13",{"name":5,"class":6},1]