NCT05784883

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
38mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Aug 2022Aug 2029

Study Start

First participant enrolled

August 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Expected
Last Updated

February 19, 2025

Status Verified

August 1, 2024

Enrollment Period

1.6 years

First QC Date

February 25, 2023

Last Update Submit

February 16, 2025

Conditions

Tricuspid Regurgitation

Keywords

Valvular heart diseaseTricuspid regurgitationElderlyGeriatricEchocardiography

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • Classification of tricuspid valve regurgitation in the elderly

    Baseline

  • Change in New York Heart Association (NYHA) functional class

    At 6, 12 and 60 months

  • All-cause mortality

    At 12 and 60 months

  • Cardiovascular mortality

    At 12 and 60 months

  • Rehospitalization for congestive heart failure

    At 12 and 60 months

Study Arms (1)

Consecutive patients ≥60-year-old presenting to the echocardiography clinic

Diagnostic Test: Echocardiography

Interventions

EchocardiographyDIAGNOSTIC_TEST

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

Consecutive patients ≥60-year-old presenting to the echocardiography clinic

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients ≥ 60 years old presenting to the echocardiography clinic.

You may qualify if:

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

You may not qualify if:

  • Poor acoustic window.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Hussein University Hospital of Al-Azhar University

Cairo, Egypt

Location

Related Publications (1)

  • Abdelghani M, Mohey S, Elnahas AM, Elshernouby KA, Muharram M, Gebaly M, Mokhaimar B, Elbadawi M, Diab RA, Abdelshafy M, Soliman O, Attia W. Tricuspid valve and right-heart chamber remodelling in elderly subjects with secondary tricuspid regurgitation. Acta Cardiol. 2024 Nov;79(9):1011-1020. doi: 10.1080/00015385.2024.2359657. Epub 2024 May 31.

    PMID: 38818766DERIVED

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyHeart Valve Diseases

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Mohammad Abdelghani, MD, PhD

    Al-Azhar Cardiology Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Cardiology - Cardiology Consultant

Study Record Dates

First Submitted

February 25, 2023

First Posted

March 27, 2023

Study Start

August 1, 2022

Primary Completion

March 1, 2024

Study Completion (Estimated)

August 1, 2029

Last Updated

February 19, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)