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Active, Not Recruiting

NCT Number: NCT05784883

Tricuspid Regurgitation in the ElderlY

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Al Hussein University Hospital of Al-Azhar University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Poor acoustic window.

Treatment and study plan

Echocardiography

Diagnostic Test

A comprehensive 2- and 3-dimensional transthoracic echocardiography (TTE) assessment of the tricuspid valve and right side of the heart at baseline.

Primary outcomes

  1. Prevalence of tricuspid valve regurgitation in the elderly

    Time frame: Baseline (at enrolment)

    Prevalence of mild, moderate, and severe TR in enrolled patients

  2. All-cause mortality

    Time frame: At 6 months

    Incidence of death from any cause

  3. Cardiovascular mortality

    Time frame: 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.

  4. Rehospitalization for congestive heart failure

    Time frame: At 6 months

    Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization.

Secondary outcomes

  1. Classification of tricuspid valve regurgitation in the elderly

    Time frame: 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.

  2. Change in New York Heart Association (NYHA) functional class

    Time frame: 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.

  3. All-cause mortality

    Time frame: At 12 and 60 months

    Incidence of death from any cause

  4. Cardiovascular mortality

    Time frame: 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.

  5. Rehospitalization for congestive heart failure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: TREY

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Mar 27, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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