Heart FailureNCT07558902
RDN for Heart Failure
A study testing Renal denervation in people with Heart Failure, run by Shanghai Golden Leaf MedTec Co. Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Renal denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2026to 13 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200030
Zhifeng Yao, Doctor, +86 18616881272, zhifengyao@126.com
About this study
Official title: 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.
Read the detailed description
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..
- Conditions
- Heart Failure
- Being tested
- Renal denervation
- Keywords
- RDN(renal denervation) treatment for Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationDevice
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Secondary outcomes (10)
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline
Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography.
Measured: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in NT-proBNP at 30 Days and 3 Months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start10 May 2026 (estimated)
- Primary completion10 Apr 2027 (estimated)
- Study completion13 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558902
- Sponsor's protocol ID
- MLWY- HF20250910
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Renal Denervation (RDN) for Heart Failure: A Single-Center, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07558902
- Acronym / sponsor ID
- MLWY- HF20250910
- Conditions
- Heart Failure
- Keywords
- RDN(renal denervation) treatment for Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Golden Leaf MedTec Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 13 Sep 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation for Heart Failure (RDN-HF) | Experimental | Device: Renal denervationParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal denervation1. 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. | Device | Renal Denervation for Heart Failure (RDN-HF) |
Primary outcome
Change in NT-proBNP from Baseline to 6 Months
Time frame: 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.
Change in Six-Minute Walk Test Distance from Baseline to 6 Months
Time frame: 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.
10 secondary outcomes
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline
Time frame: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in NT-proBNP at 30 Days and 3 Months
Time frame: 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
Time frame: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in New York Heart Association (NYHA) Functional Class
Time frame: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in 24-Hour Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in Office (Clinic) Blood Pressure
Time frame: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Changes in Heart Failure and Antihypertensive Medication Use
Time frame: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in Stroke Volume Index (SVI)
Time frame: 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')
Time frame: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Change in Pulmonary Artery Systolic Pressure (PASP)
Time frame: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal denervation in people with Heart Failure, run by Shanghai Golden Leaf MedTec Co. Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun Li, Bachelor (+86 18205271834, chun.li@brattea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NT-proBNP from Baseline to 6 Months (time frame: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.