Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation

NCT07042360 | Recruiting DMC

• 1 other identifier: 2025.229
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (3)

• Heart failure hospitalisation rate

  Heart failure hospitalization rate of subjects at 1 year

  1 year

• Tricuspid valve intervention rate

  Tricuspid valve intervention rate of subjects at 1 year

  1 year

• Cardiovascular mortality rate

  Cardiovascular mortality rate of subjects at 1 year

  1 year

Secondary Outcomes (24)

• Heart failure hospitalisation rate

  6-month

• Tricuspid valve intervention rate

  12-month

• NYHA Classification

  6-month

• NYHA Classification

  12-month

• Quality of Life measures

  6-month

Study Arms (2)

Medical treatment

Patient with \>= moderate TR for medical treatment

Diagnostic Test: ReDs Pro; Diagnostic Test: Fibroscan

Intervention

PAtient with \>= moderate TR for transcather intervention

Diagnostic Test: ReDs Pro; Diagnostic Test: Fibroscan

Interventions

ReDs Pro DIAGNOSTIC_TEST

The basic principle invovles emitting low-power electromagnetic sgnals into the lungs and measuring the dielectric properties of lung tissue The varing dielectric constants of these components result in differences in the impedance values for electromagnetic waves. Therefore, using the impedance method allows the estimation of the dielectric properties of lung tissue, which can be further converted into lung fluid content data through calculations.

Intervention; Medical treatment

Fibroscan DIAGNOSTIC_TEST

Using external ultrasound scanner to check fo rliver stiffness using acoustic energy

Intervention; Medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Shatin, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clnincal assistant professor

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 29, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): March 31, 2029
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

HK (1)