Tricuspid RegurgitationTRIREFNCT07042360
Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation
An observational study of Tricuspid Regurgitation, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- ReDs Pro and Fibroscan
- How many people
- 450 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2025to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients with >=moderate TR
- able to consent for the study.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, Shatin, 0000
Chak Yu So, 85260338536, kentso987@gmail.com
About this study
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
- Being tested
- ReDs Pro, Fibroscan
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReDs ProDiagnostic 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.
FibroscanDiagnostic test
Using external ultrasound scanner to check fo rliver stiffness using acoustic energy
| Study group | Role | What they receive |
|---|---|---|
| Medical treatment | Patient with >= moderate TR for medical treatment Receives: Diagnostic Test: ReDs Pro; Diagnostic Test: Fibroscan | |
| Intervention | PAtient with >= moderate TR for transcather intervention Receives: Diagnostic Test: ReDs Pro; Diagnostic Test: Fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure hospitalisation rate
Heart failure hospitalization rate of subjects at 1 year
Measured: 1 year
Tricuspid valve intervention rate
Tricuspid valve intervention rate of subjects at 1 year
Measured: 1 year
Cardiovascular mortality rate
Cardiovascular mortality rate of subjects at 1 year
Measured: 1 year
Secondary outcomes (24)
Heart failure hospitalisation rate
Heart failure hospitalization rate of subjects at 6-month
Measured: 6-month
Tricuspid valve intervention rate
1-year tricuspid valve intervention of subjects at 12-month
Measured: 12-month
NYHA Classification
Assess 6-month symptom burden via NYHA classification
Measured: 6-month
NYHA Classification
Assess 1 year symptom burden via NYHA classification
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12-month
Echocardiographic parameters changes
Compare changes in TAPSE/RVOT ratio in patients at 12-months vs baseline
Measured: 12-month
Echocardiographic parameters changes
Compare changes in 3D RV volume in patients at 12-months vs baseline
Measured: 12-month
Echocardiographic parameters changes
Compare changes in Right Ventricle size in patients at 12-months vs baseline using 3D Echocardiogram meaurements
Measured: 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
Measured: 12-month
Echocardiographic parameters changes
Compare changes in Left ventricular ejection fraction (LVEF) in patients at 12-months vs baseline
Measured: 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)
Measured: 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
Measured: 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
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Apr 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042360
- Sponsor's protocol ID
- 2025.229
- Acronym
- TRIREF
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT07042360
- Acronym / sponsor ID
- TRIREF / 2025.229
- Conditions
- Tricuspid Regurgitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical treatment | – | Diagnostic Test: ReDs Pro, Diagnostic Test: FibroscanPatient with >= moderate TR for medical treatment |
| Intervention | – | Diagnostic Test: ReDs Pro, Diagnostic Test: FibroscanPAtient with >= moderate TR for transcather intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with >=moderate TR
- able to consent for the study.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReDs ProThe 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. | Diagnostic test | Intervention, Medical treatment |
| FibroscanUsing external ultrasound scanner to check fo rliver stiffness using acoustic energy | Diagnostic test | Intervention, Medical treatment |
Primary outcome
Heart failure hospitalisation rate
Time frame: 1 year
Heart failure hospitalization rate of subjects at 1 year
Tricuspid valve intervention rate
Time frame: 1 year
Tricuspid valve intervention rate of subjects at 1 year
Cardiovascular mortality rate
Time frame: 1 year
Cardiovascular mortality rate of subjects at 1 year
24 secondary outcomes
Heart failure hospitalisation rate
Time frame: 6-month
Tricuspid valve intervention rate
Time frame: 12-month
NYHA Classification
Time frame: 6-month
NYHA Classification
Time frame: 12-month
Quality of Life measures
Time frame: 6-month
Quality of Life measures
Time frame: 12-month
Intensification of medical therapy
Time frame: 6-month
Intensification of medical therapy
Time frame: 6-month
Intensification of medical therapy
Time frame: 6-month
Intensification of medical therapy
Time frame: 6-month
Intensification of medical therapy
Time frame: 12-month
Intensification of medical therapy
Time frame: 12-month
Intensification of medical therapy
Time frame: 12-month
Intensification of medical therapy
Time frame: 12-month
Echocardiographic parameters changes
Time frame: 12-month
Echocardiographic parameters changes
Time frame: 12-month
Echocardiographic parameters changes
Time frame: 12-month
Echocardiographic parameters changes
Time frame: 12-month
Echocardiographic parameters changes
Time frame: 12-month
Echocardiographic parameters changes
Time frame: 12-month
Echocardiographic parameters changes
Time frame: 12-month
Echocardiographic parameters changes
Time frame: 12-month
Intensification of medical therapy
Time frame: 6-month
Echocardiographic parameters changes
Time frame: 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure hospitalisation rate (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.