Tricuspid RegurgitationTREYNCT05784883
Tricuspid Regurgitation in the ElderlY
An observational study of Tricuspid Regurgitation, run by Al-Azhar University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Echocardiography
- How many people
- 700 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients ≥ 60 years old presenting to the echocardiography clinic.
Who may be able to join
- All comer patients ≥60-year-old presenting to the echocardiography clinic
Who cannot join
- Poor acoustic window.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Echocardiography
- Keywords
- Valvular heart disease, Tricuspid regurgitation, Elderly, Geriatric, Echocardiography
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
A comprehensive 2- and 3-dimensional transthoracic echocardiography (TTE) assessment of the tricuspid valve and right side of the heart at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive patients ≥60-year-old presenting to the echocardiography clinic | Not described Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of tricuspid valve regurgitation in the elderly
Prevalence of mild, moderate, and severe TR in enrolled patients
Measured: Baseline (at enrolment)
All-cause mortality
Incidence of death from any cause
Measured: 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.
Measured: 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.
Measured: At 6 months
Secondary outcomes (5)
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.
Measured: Baseline
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.
Measured: At 6, 12 and 60 months
All-cause mortality
Incidence of death from any cause
Measured: 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.
Measured: 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.
Measured: At 12 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Aug 2022
- Primary completion1 Mar 2024
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Abdelghani, Al-Azhar University
- Investigators
- Mohammad Abdelghani, MD, PhD, Principal investigator, Al-Azhar Cardiology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784883
- Sponsor's protocol ID
- ACRI-01
- Acronym
- TREY
- Status last verified
- Aug 2024
- First submitted
- 25 Feb 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelghani M, Abdelshafy M, Muharram M, Elbadawi M, Mohey S, Elnahas AM, Elsoudi M, Magdy A, Mokhaimar B, Galal AM, Saed A, Attia W. Prevalence, Pathophysiologic Mechanisms, and Clinical Outcomes of Tricuspid Regurgitation in the Elderly: Results from the TREY Registry. Cardiology. 2026 Apr 9:1-11. doi: 10.1159/000551955. Online ahead of print.
PubMed 41955173Abdelghani 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.
PubMed 38818766
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Mechanisms, and Outcome of Tricuspid Valve Regurgitation in the Elderly
- ClinicalTrials.gov ID
- NCT05784883
- Acronym / sponsor ID
- TREY / ACRI-01
- Conditions
- Tricuspid Regurgitation
- Keywords
- Valvular heart disease, Tricuspid regurgitation, Elderly, Geriatric, Echocardiography
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive patients ≥60-year-old presenting to the echocardiography clinic | – | Diagnostic Test: Echocardiography |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients ≥ 60 years old presenting to the echocardiography clinic.
Key inclusion criteria (1 listed)
- All comer patients ≥60-year-old presenting to the echocardiography clinic
Key exclusion criteria (1 listed)
- Poor acoustic window.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyA comprehensive 2- and 3-dimensional transthoracic echocardiography (TTE) assessment of the tricuspid valve and right side of the heart at baseline. | Diagnostic test | Consecutive patients ≥60-year-old presenting to the echocardiography clinic |
Primary outcome
Prevalence of tricuspid valve regurgitation in the elderly
Time frame: Baseline (at enrolment)
Prevalence of mild, moderate, and severe TR in enrolled patients
All-cause mortality
Time frame: At 6 months
Incidence of death from any cause
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.
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.
5 secondary outcomes
Classification of tricuspid valve regurgitation in the elderly
Time frame: Baseline
Change in New York Heart Association (NYHA) functional class
Time frame: At 6, 12 and 60 months
All-cause mortality
Time frame: At 12 and 60 months
Cardiovascular mortality
Time frame: At 12 and 60 months
Rehospitalization for congestive heart failure
Time frame: At 12 and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Derived from this study: PubMed 41955173Abdelghani M, Abdelshafy M, Muharram M, Elbadawi M, Mohey S, Elnahas AM, Elsoudi M, Magdy A, Mokhaimar B, Galal AM, Saed A, Attia W. Prevalence, Pathophysiologic Mechanisms, and Clinical Outcomes of Tricuspid Regurgitation in the Elderly: Results from the TREY Registry. Cardiology. 2026 Apr 9:1-11. doi: 10.1159/000551955. Online ahead of print.
- Derived from this study: PubMed 38818766Abdelghani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Abdelghani, MD, PhD principal investigator
Al-Azhar Cardiology Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of tricuspid valve regurgitation in the elderly (time frame: Baseline (at enrolment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05784883, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.