Tricuspid Regurgitation in the ElderlY

Study Overview
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Brief Summary
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Tricuspid regurgitation (TR) is the second most common VHD after MR. Its prevalence also increases with age, with an estimated incidence of up to 6% in elderly population. When adjusted to age (among other confounders), survival is worse for patients with moderate and severe TR. We aim to explore the prevalence, mechanisms, and clinical implications of tricuspid valve regurgitation in elderly subjects screened at a tertiary center in Cairo, Egypt.

Official Title
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Prevalence, Mechanisms, and Outcome of Tricuspid Valve Regurgitation in the Elderly

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Diagnostic Test: Echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All comer patients ≥60-year-old presenting to the echocardiography clinic Exclusion Criteria: Poor acoustic window.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consecutive patients ≥60-year-old presenting to the echocardiography clinic<br> | Diagnostic Test: Echocardiography<br>* A comprehensive 2- and 3-dimensional transthoracic echocardiography (TTE) assessment of the tricuspid valve and right side of the heart at baseline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of tricuspid valve regurgitation in the elderly | Prevalence of mild, moderate, and severe TR in enrolled patients | Baseline (at enrolment) | 
| All-cause mortality | Incidence of death from any cause | At 6 months | 
| Cardiovascular mortality | Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident. | At 6 months | 
| Rehospitalization for congestive heart failure | Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization. | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of tricuspid valve regurgitation in the elderly | Classify the type of TR according to the main morphologic and/or functional abnormality. The classification will be done according to the following proposal, the TR could be 1- primary (organic) if there is an anatomical abnormality of the tricuspid valve apparatus. 2- secondary (functional) if the tricuspid valve apparatus was normal but the TR due to annular dilation. If the annular dilation is due to right ventricular volume or/and pressure overload, the TR will classify as ventricular TR, whereas if the annular dilation is due to atrial fibrillation, the TR will classify as atrial TR. The last type of TR is due to the implantation of a cardiac implantable electronic device (CIED) which will classify as CIED-related TR. | Baseline | 
| Change in New York Heart Association (NYHA) functional class | New York Heart Association [NYHA] functional class (I-IV) will be assessed in all participants at baseline and at follow-up visits (or by phone interviews). NYHA Class I: No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. NYHA Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. NYHA Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest. NYHA Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | At 6, 12 and 60 months | 
| All-cause mortality | Incidence of death from any cause | At 12 and 60 months | 
| Cardiovascular mortality | Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident. | At 12 and 60 months | 
| Rehospitalization for congestive heart failure | Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization. | At 12 and 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Valvular heart disease, Tricuspid regurgitation, Geriatric, Echocardiography