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临床试验/NCT07042360
NCT07042360招募中不适用

Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation

Prince of Wales Hospital, Shatin, Hong Kong2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
450
试验地点
2
主要终点
Heart failure hospitalisation rate

研究概览

简要总结

Tricuspid regurgitation (TR) is an increasingly recognized valvular heart disease associated with high morbidity and mortality. With the availability of various novel transcatheter tricuspid interventions, it is no longer considered a "forgotten valve." Heart failure with preserved ejection fraction (HFpEF) is a prevalent condition also characterized by high morbidity and mortality. The prevalence of moderate to severe TR in the general population is 3% to 6%; however, in patients with heart failure (with reduced or preserved ejection fraction [EF]), the prevalence is 10% to 29%, rising to up to 39% in patients with HFpEF and atrial fibrillation (AF). The EuroTR registry, an international registry including patients who underwent percutaneous treatment for severe TR, reported that 72% of patients had a left ventricular ejection fraction (LVEF) ≥50%. In a subgroup of patients with right heart catheterization data, 68% had a pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg, indicating that many of these patients may have HFpEF. Patients with significant TR have also been shown to experience irreversible liver derangement and cirrhosis. Non-invasive evaluation of liver stiffness (LS), measured by transient elastography, has recently received increased attention in patients with heart failure and has been shown to closely correlate with right-sided filling pressures. LS has been used to predict adverse outcomes in patients undergoing transcatheter aortic valve (TA) surgery with concomitant left-sided valve surgery.

On the other hand, the Remote Dielectric Sensing System (ReDS; Sensible Medical Innovations, Israel) is a device that measures lung fluid non-invasively and provides an objective and reproducible index of volume status. It is an FDAapproved device for heart failure patients. ReDS measurements are presented as the percentage of fluid relative to lung volume, with normal values ranging between 20% to 35%. Studies have demonstrated excellent correlations between the ReDS index and computed tomography (CT)-measured lung water and invasively determined hemodynamics. Additionally, it has been shown to predict heart failure rehospitalization in patients with acute heart failure.

Given the emergence of novel transcatheter tricuspid interventions and the established link between TR, HFpEF, and markers such as liver stiffness and lung fluid index (measured by ReDS), this study will examine the intricate interplay between these conditions and their shared pathophysiology. By analyzing left and right heart function, risk factors, and treatment outcomes, the research aims to phenotype TR using non-invasive assessment tools to predict clinical outcomes and improve treatment strategies for patients with different types of TR. Our findings will contribute to developing more effective and personalized treatment plans for patients with TR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with >=moderate TR
  • able to consent for the study.

排除标准

  • LVEF <=40%
  • Have significant left sided organic valvular heart disease (i.e. >=moderate AS, >=moderate MS, >=moderate MR of organic or mixed aetiology), dysfunctional mitral valve replacement or aortic valve replacement
  • Prior tricuspid valve interventions (eg TriClip, tricuspid valve repair or replacement) (To allow accurate transient elastography)
  • Known hepatocellular carcinoma
  • Known portal vein thrombosis
  • Established liver cirrhosis with a known liver-related aetiology
  • Hepatitis C infection and not on treatment
  • Uncontrolled hepatitis (e.g. hepatitis B infection, autoimmune hepatitis)
  • Fatty liver with evidence of non-alcoholic fatty liver disease or cirrhosis (to allow accurate non-invasive lung fluid assessment)
  • recent rib fracture (<3 months) with or without flail chest
  • BMI <20 or >36
  • Height <155cm or >195cm
  • Patients with right lung tumor
  • Patients with right sided pacemaker
  • Patients with known underlying exudative right pleural effusion

研究组 & 干预措施

Medical treatment

Patient with >= moderate TR for medical treatment

干预措施: ReDs Pro (Diagnostic Test)

Medical treatment

Patient with >= moderate TR for medical treatment

干预措施: Fibroscan (Diagnostic Test)

Intervention

PAtient with >= moderate TR for transcather intervention

干预措施: ReDs Pro (Diagnostic Test)

Intervention

PAtient with >= moderate TR for transcather intervention

干预措施: Fibroscan (Diagnostic Test)

结局指标

主要结局

Heart failure hospitalisation rate

时间窗: 1 year

Heart failure hospitalization rate of subjects at 1 year

Tricuspid valve intervention rate

时间窗: 1 year

Tricuspid valve intervention rate of subjects at 1 year

Cardiovascular mortality rate

时间窗: 1 year

Cardiovascular mortality rate of subjects at 1 year

次要结局

  • NYHA Classification(6-month)
  • Quality of Life measures(6-month)
  • Intensification of medical therapy(12-month)
  • Heart failure hospitalisation rate(6-month)
  • Tricuspid valve intervention rate(12-month)
  • NYHA Classification(12-month)
  • Quality of Life measures(12-month)
  • Intensification of medical therapy(6-month)
  • Echocardiographic parameters changes(12-month)

研究者

发起方
Prince of Wales Hospital, Shatin, Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr So Chak Yu kent

Clnincal assistant professor

Prince of Wales Hospital, Shatin, Hong Kong

研究点 (2)

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