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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.
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal denervation | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in NT-proBNP from Baseline to 6 Months | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular Ejection Fraction (LVEF) from Baseline | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun Li, Bachelor | Contact | +86 18205271834 | chun.li@brattea.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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1. Single-Arm Design (No Control Group) This study employs a pre-post comparison design without a parallel control or sham procedure group. Each participant serves as their own control, with baseline (pre-procedure) measurements compared against post-procedure outcomes at 30 days, 3 months, and 6 months. This design is appropriate for this pilot, exploratory study aimed at generating preliminary efficacy data and effect size estimates to inform future randomized controlled trials.
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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 | 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 | 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) | 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 | 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 | 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) | 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') | 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) | Pulmonary artery systolic pressure (PASP) assessed by transthoracic echocardiography. | Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window) |