Actively Recruiting
Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation
Led by Prince of Wales Hospital, Shatin, Hong Kong · Updated on 2025-06-29
450
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Tricuspid regurgitation (TR) is a heart valve condition increasingly recognized for its serious impact on health, especially in patients with heart failure with preserved ejection fraction (HFpEF). This condition is linked to higher risks of hospitalization and death. The study aims to understand the complex relationship between TR, heart function, and related factors like liver stiffness and lung fluid, using non-invasive tools to better predict outcomes and improve treatments for different types of TR. Participants will be grouped based on whether they receive medical treatment or transcatheter intervention for moderate or greater TR. The study uses advanced diagnostic devices such as the ReDS Pro, which measures lung fluid through electromagnetic signals, and Fibroscan, which assesses liver stiffness with ultrasound. These assessments help characterize the heart and lung conditions without invasive procedures. During the study, participants will undergo regular evaluations including heart function tests, lung fluid and liver stiffness measurements, and quality of life assessments. Researchers will track outcomes such as rates of heart failure hospitalizations, tricuspid interventions, and cardiovascular deaths over one year. The study monitors changes in heart performance and therapy adjustments to understand how these relate to patient health and treatment decisions.
CONDITIONS
Brief Title
Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with moderate or greater tricuspid regurgitation (TR)
- Able to give consent for the study
You will not qualify if you...
- Left ventricular ejection fraction (LVEF) 40% or less
- Significant left-sided organic valvular heart disease (moderate or greater aortic stenosis, mitral stenosis, or mitral regurgitation), or dysfunctional mitral or aortic valve replacement
- Prior tricuspid valve interventions such as TriClip, repair, or replacement
- Known hepatocellular carcinoma
- Known portal vein thrombosis
- Established liver cirrhosis with known liver-related cause
- Untreated hepatitis C infection
- Uncontrolled hepatitis (including hepatitis B or autoimmune hepatitis)
- Fatty liver disease with non-alcoholic fatty liver disease or cirrhosis
- Recent rib fracture within 3 months, with or without flail chest
- Body mass index (BMI) less than 20 or greater than 36
- Height less than 155 cm or greater than 195 cm
- Presence of right lung tumor
- Presence of right-sided pacemaker
- Known exudative right pleural effusion or fluid buildup in the right lung area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo non-invasive diagnostic tests including ReDs Pro and Fibroscan to assess lung and liver conditions related to tricuspid regurgitation.
1 visit (in-person)
Duration - 12 months
Participants are monitored for heart failure hospitalization, tricuspid valve intervention, cardiovascular mortality, and other health outcomes over 12 months.
Periodic visits as needed for assessments over 12 months
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong, 0000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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