Tricuspid Regurgitation in the ElderlY

Tricuspid Regurgitation Clinical Trial

— TREY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784883
• Other study ID #: ACRI-01
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: August 1, 2029

Study information

• Verified date: April 2023
• Source: Al-Azhar University
• Contact: Mohammad Abdelghani, MD, PhD
• Phone: +201125235320
• Email: m.abdelghani.nl[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: August 1, 2029
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Poor acoustic window.

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Egypt	Al Hussein University Hospital of Al-Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of tricuspid valve regurgitation in the elderly	Prevalence of mild, moderate, and severe TR in enrolled patients	Baseline (at enrolment)
Primary	All-cause mortality	Incidence of death from any cause	At 6 months
Primary	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
Primary	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	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
Secondary	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
Secondary	All-cause mortality	Incidence of death from any cause	At 12 and 60 months
Secondary	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
Secondary	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