Tricuspid RegurgitationLOCOMOTRINCT06169345
The Long-term Course of Moderate Tricuspid Regurgitation
An observational study of Tricuspid Regurgitation and Heart Failure, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Tricuspid Regurgitation, Heart Failure, Echocardiography
- What is being tested?
- Echocardiographic evaluation
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to 1 Feb 2023
- 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 95 years
- All sexes
- Adult, Older adult
Study population: Patients with an echocardiographic diagnosis of moderate tricuspid regurgitation at our center between 2010 and 2019
Who may be able to join
- Patients with an echocardiographic diagnosis of moderate TR
- Patients with echocardiographic and clinical follow-up information available at least 6-months after moderateTR diagnosis.
Who cannot join
- Absence of an appropriate clinical and echocardiographic follow-up
- A history of previous TV intervention (either surgical or percutaneous)
- The presence of concomitant TV stenosis
- Congenital heart disease
- Left ventricular assist devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Long-term Clinical Course of Moderate Tricuspid Regurgitation
To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology.
- Conditions
- Tricuspid Regurgitation, Heart Failure, Echocardiography
- Being tested
- Echocardiographic evaluation
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic evaluationOther
Echocardiographic follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Time from diagnosis to all-cause death
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
Cardiovascular (CV) mortality
The occurrence of cardiovascular (CV) mortality (defined as death due to advanced heart failure, coronary ischemic heart disease, sudden cardiac death or due to stroke
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 May 2021
- Primary completion1 Aug 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agricola Eustachio, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169345
- Sponsor's protocol ID
- LOCOMOTRI STUDY
- Acronym
- LOCOMOTRI
- Status last verified
- Dec 2023
- First submitted
- 26 Sep 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Clinical Course of Moderate Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT06169345
- Acronym / sponsor ID
- LOCOMOTRI / LOCOMOTRI STUDY
- Conditions
- Tricuspid Regurgitation, Heart Failure, Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 13 Dec 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.
To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with an echocardiographic diagnosis of moderate tricuspid regurgitation at our center between 2010 and 2019
Key inclusion criteria (2 listed)
- Patients with an echocardiographic diagnosis of moderate TR
- Patients with echocardiographic and clinical follow-up information available at least 6-months after moderateTR diagnosis.
Key exclusion criteria (5 listed)
- Absence of an appropriate clinical and echocardiographic follow-up
- A history of previous TV intervention (either surgical or percutaneous)
- The presence of concomitant TV stenosis
- Congenital heart disease
- Left ventricular assist devices
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 |
|---|---|---|
| Echocardiographic evaluationEchocardiographic follow-up | Other | – |
Primary outcome
All-cause death
Time frame: through study completion, an average of 2 years
Time from diagnosis to all-cause death
1 secondary outcome
Cardiovascular (CV) mortality
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- 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.
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 Regurgitation and Heart Failure, run by IRCCS San Raffaele 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 2 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: finished, as of the sponsor's last update on 13 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All-cause death (time frame: through study completion, an average of 2 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 13 Dec 2023.