Tricuspid Regurgitation in the ElderlY (TREY)

Prevalence, Mechanisms, and Outcome of Tricuspid Valve 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.

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Diagnostic test: Echocardiography

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Mohammad Abdelghani, MD, PhD; Phone Number: +201125235320; Email: m.abdelghani.nl@gmail.com
• Study Contact Backup: Name: Mahmoud Abdelshafy, MBBCh, MSc; Phone Number: +201030561657; Email: mahmoudabdalal7@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Al Hussein University Hospital of Al-Azhar University
    • Contact: Mahmoud Abdelshafy, MBBCh, MSc; Phone Number: +201030561657; Email: mahmoudabdalal7@gmail.com
    • Contact: Wael Attia, MD; Phone Number: +2010241401053

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Poor acoustic window.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Consecutive patients ≥60-year-old presenting to the echocardiography clinic	Diagnostic test: Echocardiography; A comprehensive 2- and 3-dimensional transthoracic echocardiography (TTE) assessment of the tricuspid valve and right side of the heart at baseline.

What is the study measuring?

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
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
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
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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Mohammad Abdelghani, MD, PhD, Al-Azhar Cardiology Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): August 1, 2029

Study Registration Dates

• First Submitted: February 25, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 1, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Echocardiography; Geriatric; Valvular heart disease; Tricuspid regurgitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: ACRI-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No