Non-invasive testing to profile tricuspid regurgitation

Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation

This project will test whether non-invasive tools like lung‑fluid monitoring (ReDs Pro) and liver FibroScan can better classify people with moderate-to-severe tricuspid regurgitation to guide care.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong (other)
• Locations: 1 site (Hong Kong, Shatin)
• Trial ID: NCT07042360 on ClinicalTrials.gov

What this trial studies

This is a single-center observational program at Prince of Wales Hospital using non-invasive devices (ReDs Pro for lung fluid and transient elastography/FibroScan for liver stiffness) alongside standard cardiac imaging to phenotype tricuspid regurgitation. Eligible participants have at least moderate TR and are able to give consent, while patients with LVEF ≤40%, significant left-sided valvular disease, prior tricuspid interventions, or active liver disease are excluded. The approach aims to link extracardiac measures of congestion and liver stiffness with TR severity and heart-failure features, particularly HFpEF and atrial fibrillation. Findings will be descriptive and hypothesis-generating to help match patient features to emerging transcatheter tricuspid therapies.

Who should consider this trial

Good fit: Ideal candidates are adults with at least moderate tricuspid regurgitation who can consent, have LVEF >40%, and do not have significant left-sided valve disease or active liver disease.

Not a fit: Patients with LVEF ≤40%, significant left-sided organic valvular disease, prior tricuspid interventions, known liver cancer, portal vein thrombosis, established cirrhosis or uncontrolled hepatitis, or those outside the BMI/height windows are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could help identify which patients with tricuspid regurgitation are most likely to benefit from particular transcatheter or medical treatments.

How similar studies have performed: Large registries and percutaneous tricuspid programs have described outcomes of interventions, but the combined use of non-invasive lung‑fluid monitoring and FibroScan for systematic TR phenotyping is relatively novel with limited prior data.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. LVEF \<=40%
2. 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
3. Prior tricuspid valve interventions (eg TriClip, tricuspid valve repair or replacement) (To allow accurate transient elastography)
4. Known hepatocellular carcinoma
5. Known portal vein thrombosis
6. Established liver cirrhosis with a known liver-related aetiology
7. Hepatitis C infection and not on treatment
8. Uncontrolled hepatitis (e.g. hepatitis B infection, autoimmune hepatitis)
9. Fatty liver with evidence of non-alcoholic fatty liver disease or cirrhosis (to allow accurate non-invasive lung fluid assessment)
10. recent rib fracture (\<3 months) with or without flail chest
11. BMI \<20 or \>36
12. Height \<155cm or \>195cm
13. Patients with right lung tumor
14. Patients with right sided pacemaker
15. Patients with known underlying exudative right pleural effusion

Where this trial is running

Hong Kong, Shatin

• Prince of Wales Hospital — Hong Kong, Shatin, Hong Kong (RECRUITING)

Conditions: Tricuspid Regurgitation