Heart Valve IncompetenceASTRANCT05749107
In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation
An observational study of Heart Valve Incompetence and Atrial Fibrillation, Persistent, run by Istituto Auxologico Italiano at 2 sites in Italy.
Trial summary
1050 patients with persistent/permanent atrial fibrillation (AF) will be studied using conventional and advanced (three-dimensional and deformation imaging) echocardiography. Patients with moderate/severe isolated secondary tricuspid regurgitation (STR) will undergo blood tests to assess their proteomic profile and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Incompetence, Atrial Fibrillation, Persistent
- What is being tested?
- Echocardiography and Proteomic analyses
- How many people
- 1,050 participants
- Where
- 2 sitesItaly
- Study dates
- 2 Dec 2022to 2 Nov 2025
- How long will I take part?
- 36 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing echocardiography stud because of persistent/permanent atrial fibrillation
Who may be able to join
- age> 18 years
- persistent/permanent atrial fibrillation
- good acoustic apical window
- left ventricular ejection fraction > 50%
- pulmonary artery systolic pressure< 50 mm Hg
- no more than mild mitral or aortic valve disease
- ability to attend clinical and echocardiographic follow-ups
- signature of the study informed consent
Who cannot join
- pregnancy
- implanted pace-maker or ICD
- previous heart valve surgery or transcatheter treatment
- previous heart transplant
- organic tricuspid regurgitation
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Istituto Auxologico Italiano, IRCCS
Milan, Select A State, 20149
Luigi Badano, MD, Ph.D., +3902619111 ext. 2319, l.badano@auxologico.it
Denisa Muraru, MD, Ph.D., +3902619111 ext. 2319, d.muraru@auxologico.it
- Not yet recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
Pasquale Vergara, MD, Ph.D., vergara.pasquale@hsr.it
About this study
Official title: In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation. Prevalence, Mechanisms, Advanced Quantification of Regurgitation Severity, and Relative Impact of Sinus Rhythm Restoration on the 3D Remodeling of Right Heart Chambers and Tricuspid Valve Apparatus
1050 patients with persistent/permanent atrial fibrillation (AF) will be studied using conventional and advanced (three-dimensional and deformation imaging) echocardiography. Patients with moderate/severe isolated secondary tricuspid regurgitation (STR) will undergo blood tests to assess their proteomic profile and cardiac CT to measure the tricuspid annulus geometry. The project will aim to 1. assess the prevalence of moderate/severe isolated STR in patients with AF; 2. identify the mechanisms associated with the development of moderate-severe STR in patients with AF; 3. identify the proteomic profile associated with significant growth of tricuspid valve leaflets as a mechanism to protect patients with AF from the development of moderate/severe STR; 4. evaluate the effects of the restoration of sinus rhythm on the severity of STR and the remodeling of the right heart cardiac structures (i.e. right ventricle, right atrium, and tricuspid valve apparatus).
- Being tested
- Echocardiography, Proteomic analyses
- Keywords
- Functional tricuspid regurgitation, Three-dimensional echocardiography, Doppler echocardiography, Right ventricular function, Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Identify AF patients at risk of developing moderate/severe STR and those who will benefit from restoring the normal sinus rhythm
Proteomic analysesCombination product
To identify the mechanisms leading to moderate/severe STR during AF.
| Study group | Role | What they receive |
|---|---|---|
| Atrial secondary tricuspid regurgitation | Patients with persistent/permanent atrial fibrillation and any degree of isolated tricuspid regurgitation Receives: Diagnostic Test: Echocardiography; Combination Product: Proteomic analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of either moderate or severe functional tricuspid regurgitation
To assess the prevalence of moderate or severe atriogenic secondary tricuspid regurgitation (STR) in patients with persistent/permanent atrial fibrillation (AF), and to develop valve-specific metrics and parameters to assess STR severity by echocardiography.
Measured: 1 year
To identify the mechanisms leading to moderate/severe STR during AF.
STR severity varies among patients with persistent/permanent AF and comparable RV and RA remodeling. The role of RV and RA size, shape, and function on the extent of tricuspid annulus dilation and dysfunction remains to be clarified.
Moreover, it is unknown whether the leaflets of the tricuspid valve can adapt to the stretch exerted on them by the progressive dilation of the tricuspid annulus. The contribution of leaflet adaptation to the pathophysiology of STR and its molecular determinants remains to be clarified
Measured: 3 years
To evaluate the extent of the right heart structure remodeling occurring after the recovery of the sinus rhythm and its effects on STR severity.
Patients undergoing sustained cardioversion to sinus rhythm (both electrical and pharmacological) and/or ablation of AF, will be followed at 1, 3, and 12 months after the procedure by recording electrocardiogram and complete 2D Doppler and 3DE to assess the extent of the remodeling of the RV, the RA, and the tricuspid valve apparatus. Patients with atriogenic moderate/severe STR without clinical indication to either cardioversion or ablation of the AF, and patients with none/mild atriogenic STR will be followed with clinical assessment, and complete 2D, Doppler and 3DE at 6 months and 1 year.
The severity of STR will be quantified by measuring EROA, regurgitant volume, and regurgitant fraction.
Measured: 3 years
Secondary outcomes (1)
Development of an interpretable predictive model by using and integrating a variety of statistical and artificial intelligence (AI) techniques.
Clinical, echocardiographic, and biomarker parameters that might predict either the development of moderate/severe STR in patients with AF or the likelihood of reduction of STR severity after cardioversion in sinus rhythm will be identified and integrated in an expert system based on fuzzy reasoning.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start2 Dec 2022
- Primary completion2 Dec 2024 (estimated)
- Study completion2 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve IncompetenceStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- 1,050 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749107
- Sponsor's protocol ID
- 09M202
- Acronym
- ASTRA
- Status last verified
- Mar 2024
- First submitted
- 18 Feb 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation. Prevalence, Mechanisms, Advanced Quantification of Regurgitation Severity, and Relative Impact of Sinus Rhythm Restoration on the 3D Remodeling of Right Heart Chambers and Tricuspid Valve Apparatus
- ClinicalTrials.gov ID
- NCT05749107
- Acronym / sponsor ID
- ASTRA / 09M202
- Keywords
- Functional tricuspid regurgitation, Three-dimensional echocardiography, Doppler echocardiography, Right ventricular function, Atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 2 Dec 2024 (estimated)
- Study completion
- 2 Nov 2025 (estimated)
- First posted
- 1 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.
1050 patients with persistent/permanent atrial fibrillation (AF) will be studied using conventional and advanced (three-dimensional and deformation imaging) echocardiography. Patients with moderate/severe isolated secondary tricuspid regurgitation (STR) will undergo blood tests to assess their proteomic profile and cardiac CT to measure the tricuspid annulus geometry. The project will aim to 1. assess the prevalence of moderate/severe isolated STR in patients with AF; 2. identify the mechanisms associated with the development of moderate-severe STR in patients with AF; 3. identify the proteomic profile associated with significant growth of tricuspid valve leaflets as a mechanism to protect patients with AF from the development of moderate/severe STR; 4. evaluate the effects of the restoration of sinus rhythm on the severity of STR and the remodeling of the right heart cardiac structures (i.e. right ventricle, right atrium, and tricuspid valve apparatus).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial secondary tricuspid regurgitation | – | Diagnostic Test: Echocardiography, Combination Product: Proteomic analysesPatients with persistent/permanent atrial fibrillation and any degree of isolated tricuspid regurgitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing echocardiography stud because of persistent/permanent atrial fibrillation
Key inclusion criteria (8 listed)
- age> 18 years
- persistent/permanent atrial fibrillation
- good acoustic apical window
- left ventricular ejection fraction > 50%
- pulmonary artery systolic pressure< 50 mm Hg
Key exclusion criteria (5 listed)
- pregnancy
- implanted pace-maker or ICD
- previous heart valve surgery or transcatheter treatment
- previous heart transplant
- organic tricuspid regurgitation
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 |
|---|---|---|
| EchocardiographyIdentify AF patients at risk of developing moderate/severe STR and those who will benefit from restoring the normal sinus rhythm | Diagnostic test | Atrial secondary tricuspid regurgitation |
| Proteomic analysesTo identify the mechanisms leading to moderate/severe STR during AF. | Combination product | Atrial secondary tricuspid regurgitation |
Primary outcome
Incidence of either moderate or severe functional tricuspid regurgitation
Time frame: 1 year
To assess the prevalence of moderate or severe atriogenic secondary tricuspid regurgitation (STR) in patients with persistent/permanent atrial fibrillation (AF), and to develop valve-specific metrics and parameters to assess STR severity by echocardiography.
To identify the mechanisms leading to moderate/severe STR during AF.
Time frame: 3 years
STR severity varies among patients with persistent/permanent AF and comparable RV and RA remodeling. The role of RV and RA size, shape, and function on the extent of tricuspid annulus dilation and dysfunction remains to be clarified. Moreover, it is unknown whether the leaflets of the tricuspid valve can adapt to the stretch exerted on them by the progressive dilation of the tricuspid annulus. The contribution of leaflet adaptation to the pathophysiology of STR and its molecular determinants remains to be clarified
To evaluate the extent of the right heart structure remodeling occurring after the recovery of the sinus rhythm and its effects on STR severity.
Time frame: 3 years
Patients undergoing sustained cardioversion to sinus rhythm (both electrical and pharmacological) and/or ablation of AF, will be followed at 1, 3, and 12 months after the procedure by recording electrocardiogram and complete 2D Doppler and 3DE to assess the extent of the remodeling of the RV, the RA, and the tricuspid valve apparatus. Patients with atriogenic moderate/severe STR without clinical indication to either cardioversion or ablation of the AF, and patients with none/mild atriogenic STR will be followed with clinical assessment, and complete 2D, Doppler and 3DE at 6 months and 1 year. The severity of STR will be quantified by measuring EROA, regurgitant volume, and regurgitant fraction.
1 secondary outcome
Development of an interpretable predictive model by using and integrating a variety of statistical and artificial intelligence (AI) techniques.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Incompetence and Atrial Fibrillation, Persistent, run by Istituto Auxologico Italiano at 2 sites 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 8 inclusion and 5 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Luigi Badano, MD, Ph.D. (+390261911 ext. 2319, l.badano@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of either moderate or severe functional tricuspid regurgitation (time frame: 1 year). The study lists 3 primary outcomes in all. 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 Mar 2024.