Actively Recruiting

Age: 18Years +
All Genders
NCT07042360

Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation

Led by Prince of Wales Hospital, Shatin, Hong Kong · Updated on 2025-06-29

450

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with moderate or greater tricuspid regurgitation
  • Able to give consent for the study
Not Eligible

You will not qualify if you...

  • Left ventricular ejection fraction less than or equal to 40%
  • Significant left-sided valvular heart disease (moderate or greater aortic stenosis, mitral stenosis, or mitral regurgitation), or dysfunctional mitral or aortic valve replacement
  • Prior tricuspid valve interventions such as TriClip, repair, or replacement
  • Known hepatocellular carcinoma
  • Known portal vein thrombosis
  • Established liver cirrhosis with known liver-related cause
  • Untreated hepatitis C infection
  • Uncontrolled hepatitis B, autoimmune hepatitis, or other uncontrolled hepatitis
  • Fatty liver disease with evidence of non-alcoholic fatty liver disease or cirrhosis
  • Recent rib fracture within the past 3 months
  • Body mass index less than 20 or greater than 36
  • Height less than 155 cm or greater than 195 cm
  • Presence of right lung tumor
  • Presence of right sided pacemaker
  • Known exudative right pleural effusion

AI-Screening

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Hong Kong, Shatin, Hong Kong, 0000

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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