Tricuspid Regurgitation in the ElderlY

Active, not recruiting

• Conditions: Tricuspid Regurgitation
• Interventions: Diagnostic Test: Echocardiography

• Registration Number: NCT05784883
• Lead Sponsor: Al-Azhar University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2023-02-25
• Study First Submitted QC: 2023-03-14
• Study First Posted: 2023-03-27
• Primary Completion: 2024-03-01
• Status Verified: 2024-08
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• All comer patients ≥60-year-old presenting to the echocardiography clinic

Exclusion Criteria

• Poor acoustic window.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Consecutive patients ≥60-year-old presenting to the echocardiography clinic	Echocardiography	-

Primary Outcome Measures

Name	Time	Method
Prevalence of tricuspid valve regurgitation in the elderly	Baseline (at enrolment)	Prevalence of mild, moderate, and severe TR in enrolled patients
All-cause mortality	At 6 months	Incidence of death from any cause
Rehospitalization for congestive heart failure	At 6 months	Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization.
Cardiovascular mortality	At 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Classification of tricuspid valve regurgitation in the elderly	Baseline	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.
Change in New York Heart Association (NYHA) functional class	At 6, 12 and 60 months	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.
All-cause mortality	At 12 and 60 months	Incidence of death from any cause
Cardiovascular mortality	At 12 and 60 months	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.
Rehospitalization for congestive heart failure	At 12 and 60 months	Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization.

Trial Locations

Locations (1)

Al Hussein University Hospital of Al-Azhar University; 🇪🇬 Cairo, Egypt