RDN for Heart Failure

Starting soon · Not applicable · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT07558902

Run by

Shanghai Golden Leaf MedTec Co. Ltd

People needed

20

Starts

2026-05-10

Expected to finish

2027-09-13

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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