Tricuspid Valve InsufficiencyATOMICNCT05724225
"Atriogenic Tricuspid Selected, Omics Profile, Multimodality Imaging and Clinical Outcomes"
An observational study of Tricuspid Valve Insufficiency, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of our study is to investigate the molecular mechanisms underlying remodeling of the tricuspid valve apparatus in patients with ITF and isolated AF, in comparison with patients with ITF from right ventricular remodeling, patients with atriogenic MI and left ventricular remodeling. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tricuspid Valve Insufficiency
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 6 Oct 2021to 29 Dec 2023
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with persistent atrial fibrillation
Who may be able to join
- Admitted to the Department of cardiological, neurological and metabolic sciences of the San Luca hospital with a diagnosis of persistent atrial fibrillation
Who cannot join
- Patient aged <18 years;
- Pregnancy;
- Chronic inflammatory diseases;
- Autoimmune diseases;
- Tumor diseases;
- Chronic renal failure with eGFR < 30 mL/min;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atriogenic Tricuspid Regurgitation, Selected Omics Profile, Multimodality Imaging and Clinical Outcomes (the ATOMIC Study)
The aim of our study is to investigate the molecular mechanisms underlying remodeling of the tricuspid valve apparatus in patients with ITF and isolated AF, in comparison with patients with ITF from right ventricular remodeling, patients with atriogenic MI and left ventricular remodeling. To achieve these aims, markers obtained from cardiovascular imaging methods, such as 3D echocardiogram, and biomarkers isolated from the peripheral blood of the study participants will be considered.
Read the detailed description
Advances in echocardiography and, in particular, the development of three-dimensional echocardiography have allowed a more accurate analysis of the morphology of the tricuspid valve and a detailed understanding of the mechanisms underlying its insufficiency. From a clinical point of view, ITF is divided into a primary form, less frequent (8-10%), caused by primary alterations of the tricuspid valve apparatus, acquired or congenital, and in a "functional" form, the most frequent, conventionally associated in most cases with coexisting pathologies of the left heart or primitive pathologies of the right heart. More recently, long-lasting persistent atrial fibrillation (AF) has been associated with the development of ITF in the presence of structurally normal valve leaflets, preserved right ventricular size and function, and right atrial dilatation. This form of ITF, defined as "atrial functional", could benefit from a different therapeutic management compared to the classic form, more commonly caused by right ventricular dilatation and dysfunction ("ventricular functional" IT). However, not all patients with AF and tricuspid annulus dilatation develop valvular insufficiency and, on the other hand, with the same valvular annulus dilatation and right atrial size, the prevalence of severe IT forms is extremely variable.
This could depend on different adaptive mechanisms implemented by the valve leaflet tissue that lead to their growth or not in response to atrial remodeling and valve annulus dilatation, representing a key factor in the development and progression of the disease. Atriogenic ITF. If confirmed, these observations could lead to a better prognostic classification and different therapeutic perspectives for patients with AF at risk of developing forms of severe ITF and congestive heart failure.
- Conditions
- Tricuspid Valve Insufficiency
- Keywords
- functional tricuspid valve regurgitation, atrial fibrillation
- Medical subject headings
- Tricuspid Valve Insufficiency, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| First group with atrial fibrillation disease | 10 Atrial fibrillation(AF), predominant right atrial dilatation with at least moderate IT | |
| Second group with atrial fibrillation disease and tricuspid insufficiency | 10 AF, predominantly right atrial dilatation without TI (or TI no more than mild) | |
| Third group with AF and mitral insufficiency | 10 AF, predominantly left atrial dilatation with at least moderate MI | |
| Fourth group with atrial fibrillation and IM | 10 AF, predominantly left atrial dilatation without MI (or no more than mild MI) | |
| Fifth group with tricuspid insufficiency | 10 IT at least moderate to right ventricular remodeling in patients with pulmonary hypertension | |
| Sixth group with mitral insufficiency | 10 MI at least average from left ventricular remodeling from left ventricular dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein expression
Evaluation of the protein expression of the altered biomarkers in the 6 study groups
Measured: 1 years
Secondary outcomes (2)
Correlation between circulating protein biomarkers and diagnostic parameters
Analysis of the correlation between circulating protein biomarkers and echocardiographic parameters of mitral and tricuspid valve leaflet remodeling
Measured: 6 months
Correlation between clinical data and diagnostic imaging markers
Evaluation of the correlation between clinical data (gender, age, AF duration) and echocardiographic imaging markers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start6 Oct 2021
- Primary completion7 Nov 2022
- Study completion29 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedicino Daniela, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724225
- Sponsor's protocol ID
- 4424
- Acronym
- ATOMIC
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All informtions about the patient is collected in a case report
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atriogenic Tricuspid Regurgitation, Selected Omics Profile, Multimodality Imaging and Clinical Outcomes (the ATOMIC Study)
- ClinicalTrials.gov ID
- NCT05724225
- Acronym / sponsor ID
- ATOMIC / 4424
- Conditions
- Tricuspid Valve Insufficiency
- Keywords
- functional tricuspid valve regurgitation, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 13 Feb 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.
The aim of our study is to investigate the molecular mechanisms underlying remodeling of the tricuspid valve apparatus in patients with ITF and isolated AF, in comparison with patients with ITF from right ventricular remodeling, patients with atriogenic MI and left ventricular remodeling. To achieve these aims, markers obtained from cardiovascular imaging methods, such as 3D echocardiogram, and biomarkers isolated from the peripheral blood of the study participants will be considered.
Detailed description
Advances in echocardiography and, in particular, the development of three-dimensional echocardiography have allowed a more accurate analysis of the morphology of the tricuspid valve and a detailed understanding of the mechanisms underlying its insufficiency. From a clinical point of view, ITF is divided into a primary form, less frequent (8-10%), caused by primary alterations of the tricuspid valve apparatus, acquired or congenital, and in a "functional" form, the most frequent, conventionally associated in most cases with coexisting pathologies of the left heart or primitive pathologies of the right heart. More recently, long-lasting persistent atrial fibrillation (AF) has been associated with the development of ITF in the presence of structurally normal valve leaflets, preserved right ventricular size and function, and right atrial dilatation. This form of ITF, defined as "atrial functional", could benefit from a different therapeutic management compared to the classic form, more commonly caused by right ventricular dilatation and dysfunction ("ventricular functional" IT). However, not all patients with AF and tricuspid annulus dilatation develop valvular insufficiency and, on the other hand, with the same valvular annulus dilatation and right atrial size, the prevalence of severe IT forms is extremely variable.
This could depend on different adaptive mechanisms implemented by the valve leaflet tissue that lead to their growth or not in response to atrial remodeling and valve annulus dilatation, representing a key factor in the development and progression of the disease. Atriogenic ITF. If confirmed, these observations could lead to a better prognostic classification and different therapeutic perspectives for patients with AF at risk of developing forms of severe ITF and congestive heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| First group with atrial fibrillation disease | – | –10 Atrial fibrillation(AF), predominant right atrial dilatation with at least moderate IT |
| Second group with atrial fibrillation disease and tricuspid insufficiency | – | –10 AF, predominantly right atrial dilatation without TI (or TI no more than mild) |
| Third group with AF and mitral insufficiency | – | –10 AF, predominantly left atrial dilatation with at least moderate MI |
| Fourth group with atrial fibrillation and IM | – | –10 AF, predominantly left atrial dilatation without MI (or no more than mild MI) |
| Fifth group with tricuspid insufficiency | – | –10 IT at least moderate to right ventricular remodeling in patients with pulmonary hypertension |
| Sixth group with mitral insufficiency | – | –10 MI at least average from left ventricular remodeling from left ventricular dysfunction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent atrial fibrillation
Key inclusion criteria (1 listed)
- Admitted to the Department of cardiological, neurological and metabolic sciences of the San Luca hospital with a diagnosis of persistent atrial fibrillation
Key exclusion criteria (6 listed)
- Patient aged <18 years;
- Pregnancy;
- Chronic inflammatory diseases;
- Autoimmune diseases;
- Tumor diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Protein expression
Time frame: 1 years
Evaluation of the protein expression of the altered biomarkers in the 6 study groups
2 secondary outcomes
Correlation between circulating protein biomarkers and diagnostic parameters
Time frame: 6 months
Correlation between clinical data and diagnostic imaging markers
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Yes. All informtions about the patient is collected in a case report
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Valve Insufficiency, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. 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 Italy. 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?
Results are not available in the source record.
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?
Protein expression (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.