An observational study in Tricuspid Regurgitation, sponsored by Prince of Wales Hospital, Shatin, Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Prince of Wales Hospital, Shatin, Hong Kong · Observational
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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.
227 studies on the registry are indexed under Tricuspid Valve Insufficiency; 110 are open to participants now.
This study's planned enrollment of 450 is above the median of 200 across 94 observational studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Prince of Wales Hospital, Shatin, Hong Kong is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient with \>= moderate TR for medical treatment
Diagnostic Test: ReDs Pro · Diagnostic Test: Fibroscan
PAtient with \>= moderate TR for transcather intervention
Diagnostic Test: ReDs Pro · Diagnostic Test: Fibroscan
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.
Using external ultrasound scanner to check fo rliver stiffness using acoustic energy
Heart failure hospitalisation rate
Heart failure hospitalization rate of subjects at 1 year
Time frame: 1 year
Tricuspid valve intervention rate
Tricuspid valve intervention rate of subjects at 1 year
Time frame: 1 year
Cardiovascular mortality rate
Cardiovascular mortality rate of subjects at 1 year
Time frame: 1 year
Heart failure hospitalisation rate
Heart failure hospitalization rate of subjects at 6-month
Time frame: 6-month
Tricuspid valve intervention rate
1-year tricuspid valve intervention of subjects at 12-month
Time frame: 12-month
NYHA Classification
Assess 6-month symptom burden via NYHA classification
Time frame: 6-month
NYHA Classification
Assess 1 year symptom burden via NYHA classification
Time frame: 12-month
Quality of Life measures
Assess Quality of Life measures of subject at 6-month via Kansas City Cardiomyophthy Questionnaire-12. Score range from 0-100, higher score indicates better outcome (Better Quality of Life/ less affected by Symptoms)
Time frame: 6-month
Quality of Life measures
Assess Quality of Life measures of subject at 12-month via Kansas City Cardiomyophthy Questionnaire-12 Score range from 0-100, higher score indicates better outcome (Better Quality of Life/ less affected by Symptoms)
Time frame: 12-month
Intensification of medical therapy
To monitor the short term use of intravenous diuretics at day-center at 6-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation
Time frame: 6-month
Intensification of medical therapy
To monitor the increase of total daily dose oral diuretics at day-center at 6-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation
Time frame: 6-month
Intensification of medical therapy
To monitor the short term use of inotrope at day-center at 6-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation
Time frame: 6-month
Intensification of medical therapy
To monitor the application of aquapheresis at day-center at 6-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation
Time frame: 6-month
Intensification of medical therapy
To monitor the short term use of intravenous diuretics at day-center at 12-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation
Time frame: 12-month
Intensification of medical therapy
To monitor the increase of total daily dose oral diuretics at day-center at 12-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation
Time frame: 12-month
Intensification of medical therapy
To monitor the short term use of inotrope at day-center at 12-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation
Time frame: 12-month
Intensification of medical therapy
To monitor the application of aquapheresis at day-center at 12-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation
Time frame: 12-month
Echocardiographic parameters changes
Compare changes in TAPSE in patients at 12-months vs baseline using 3D Echocardiogram meaurements at 12-month follow up
Time frame: 12-month
Echocardiographic parameters changes
Compare changes in 3D Right Ventricle Ejection Fraction (RVEF) using 3D Echocardiogram meaurements in patients at 12-months vs baseline
Time frame: 12-month
Echocardiographic parameters changes
Compare changes in TAPSE/RVOT ratio in patients at 12-months vs baseline
Time frame: 12-month
Echocardiographic parameters changes
Compare changes in 3D RV volume in patients at 12-months vs baseline
Time frame: 12-month
Echocardiographic parameters changes
Compare changes in Right Ventricle size in patients at 12-months vs baseline using 3D Echocardiogram meaurements
Time frame: 12-month
Echocardiographic parameters changes
Compare changes in Right Ventricle Systolic Pressure (RVSP) in patients at 12-months vs baseline using 3D Echocardiogram meaurements at 12-month follow up
Time frame: 12-month
Echocardiographic parameters changes
Compare changes in Left ventricular ejection fraction (LVEF) in patients at 12-months vs baseline
Time frame: 12-month
Echocardiographic parameters changes
Compare changes in Left ventricular global longitudinal strain (LV GLS) in patients at 12-months vs baseline 8. 1 year worsening of left ventricular function (LVEF, GLS, LVOT VTI)
Time frame: 12-month
Intensification of medical therapy
6-month intensification of medical therapy of subjects (including short term use of intravenous diuretics at day-center, increase oral diuretics dose or frequency, short term use of inotrope at day-center, application of aquapheresis
Time frame: 6-month
Echocardiographic parameters changes
Compare changes in Left ventricular outflow tract (LVOT VTI) in patients at 12-months vs baseline using 3D Echocardiogram meaurements at 12-month follow up
Time frame: 12-month
Started Apr 2025 (actual). Primary completion is estimated for Mar 2029, 47 months after the start.
Of 46 observational studies under Tricuspid Valve Insufficiency, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 106. This study's planned 47 months is below that.
How these figures are worked out, and which studies are left out of them.
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Tricuspid Valve Insufficiency →
Prince of Wales Hospital, Shatin, Hong Kong