Non-invasive testing to profile tricuspid regurgitation
Official title: Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation
Run by Prince of Wales Hospital, Shatin, Hong Kong · NCT07042360 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Prince of Wales Hospital, Shatin, Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Shatin) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | March 31, 2029 |
| Study ends | March 31, 2029 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT07042360 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong Recruiting
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.