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RDN for Heart Failure

2026년 4월 27일 업데이트: Shanghai Golden Leaf MedTec Co. Ltd

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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..

연구 유형

중재적

등록 (추정된)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 200030
        • Zhongshan Hospital Fudan University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Aged >18 years and ≤75 years with a clinical diagnosis of heart failure.
  2. 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).
  3. Symptomatic with exertional dyspnea or chest tightness; New York Heart Association (NYHA) functional class II or III.
  4. Serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level ≥500 pg/mL at screening.
  5. 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:

  1. Pregnancy or planned pregnancy.
  2. 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).
  3. Presence of a single kidney, history of renal transplantation, or estimated glomerular filtration rate (eGFR) <40 mL/min/1.73m².
  4. Acute heart failure episode or decompensation within 1 month prior to enrollment.
  5. Office systolic blood pressure (OSBP) ≤100 mmHg or 24-hour mean ambulatory systolic blood pressure (24hASBP) <90 mmHg.
  6. Secondary hypertension (e.g., primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid disorders, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).
  7. History of allergy or hypersensitivity to contrast media.
  8. 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.
  9. Symptomatic orthostatic hypotension.
  10. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or dilated cardiomyopathy.
  11. Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus (HbA1c >6.5%).
  12. Primary pulmonary arterial hypertension.
  13. 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).
  14. History of systemic embolism within 6 months.
  15. History of stroke or transient ischemic attack (TIA) within 6 months.
  16. Severe peripheral vascular disease or abdominal aortic aneurysm.
  17. Significant (severe) valvular heart disease.
  18. 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.
  19. Severe hepatic impairment (alanine aminotransferase [ALT], aspartate aminotransferase [AST], or total bilirubin >3 times the upper limit of normal [ULN]).
  20. Concomitant serious medical conditions that would interfere with study participation or affect survival, such as malignancy or acquired immunodeficiency syndrome (AIDS).
  21. Acute or severe systemic infection.
  22. Conditions associated with chronic high-output states, such as severe anemia, advanced liver disease, hyperthyroidism, or arteriovenous fistula.
  23. Any condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Renal Denervation for Heart Failure (RDN-HF)
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.
장치: Renal denervation

  1. 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in NT-proBNP from Baseline to 6 Months
기간: 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.
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
기간: 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.
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline
기간: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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
기간: 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 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
기간: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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
기간: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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)
기간: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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
기간: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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
기간: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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)
기간: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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')
기간: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
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)
기간: Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)
Pulmonary artery systolic pressure (PASP) assessed by transthoracic echocardiography.
Baseline (Day 0, pre-procedure) to 6 months post-procedure (±30 days window)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Shanghai Golden Leaf MedTec Co. Ltd

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 10일

기본 완료 (추정된)

2027년 4월 10일

연구 완료 (추정된)

2027년 9월 13일

연구 등록 날짜

최초 제출

2026년 2월 27일

QC 기준을 충족하는 최초 제출

2026년 4월 27일

처음 게시됨 (실제)

2026년 4월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 4월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 27일

마지막으로 확인됨

2026년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MLWY- HF20250910

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아니요

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아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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