About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with >=moderate TR
able to consent for the study.
Disqualifiers
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
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
ReDs Pro
Diagnostic testThe 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.
Fibroscan
Diagnostic testUsing external ultrasound scanner to check fo rliver stiffness using acoustic energy
Treatment groups
Trial outcomes
Primary outcomes
Heart failure hospitalisation rate
Heart failure hospitalization rate of subjects at 1 year
Tricuspid valve intervention rate
Tricuspid valve intervention rate of subjects at 1 year
Cardiovascular mortality rate
Cardiovascular mortality rate of subjects at 1 year
Secondary outcomes
Heart failure hospitalisation rate
Heart failure hospitalization rate of subjects at 6-month
Tricuspid valve intervention rate
1-year tricuspid valve intervention of subjects at 12-month
NYHA Classification
Assess 6-month symptom burden via NYHA classification
NYHA Classification
Assess 1 year symptom burden via NYHA classification
Sponsors and contacts
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