RDN for Heart Failure (NCT07558902) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
RDN for Heart Failure
China20 participantsStarted 2026-05-10
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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
✕. 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).
✕
What they're measuring
1
Change in NT-proBNP from Baseline to 6 Months
Timeframe: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
2
Change in Six-Minute Walk Test Distance from Baseline to 6 Months
Timeframe: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
✕. 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.