Remodeling, CardiacTRAPNCT03159923
Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation
An observational study of Remodeling, Cardiac and Tricuspid Regurgitation, run by Rennes University Hospital at 17 sites in France.
Trial summary
The aim of this study is to improve the definition of the two main types of secondary tricuspid regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Remodeling, Cardiac, Tricuspid Regurgitation
- What is being tested?
- Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.
- How many people
- 200 participants
- Where
- 17 sitesFrance
- Study dates
- 19 Jan 2017to 23 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography, in patients stabilized.
Who may be able to join
- Any patients ≥ 18 years old, with moderate to severe tricuspid regurgitation (≥ 2/4), agreeing to participate ;
- The patients included can be ambulatory patients or stabilized hospitalised patients (meaning patient clinicaly stable, not decompensated, and whose normovolemia has been checked).
- Non opposition of the patient
Who cannot join
- Patient whose accoustic window is judged by the operator as incompatible with a precise evaluation of the tricuspid regurgitation or anatomy of the right cavity ;
- TR < grade 2 ;
- TR secondary to primary pulmonary hypertension or congenital cardiopathy ;
- Primary tricuspid regurgitation (due to rheumatic heart disease, medication - included benfluorex, due to endocarditis, valvular prolapse, carcinoid syndrom or a cardiac stimulation lead …) ;
- Significant left heart valvulopathy (Mitral regurgitation > grade 2, Aortic insufficiency > grade 2, Mitral stenosis < 2 cm², Aortic stenosis < 1.5 cm²). A valvulopathy sucessfully operated isn't considered as an exclusion criteria;
- Cardiopathy with significative systolic dysfunction (FE< 40%) ;
- Patients whose life expectantcy is less than 1 year due to a pathology independent of the TR (neoplasic process for example) ;
- Patient under judicial protection.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Chu Amiens-Picardie - Site Sud
Amiens, 80054
Ap-Hp - Hopital Henri Mondor
Créteil, 94000
CHU de DIJON - HOPITAL FRANCOIS MITTERAND
Dijon, 21034
Chu Grenoble - Michallon
Grenoble, 38043
Ghicl - Hopital Saint Philibert
Lomme, 59462
Chu Marseille - Hopital Nord
Marseille, 13015
Hôpital Saint Joseph
Marseille, 13285
Clinique Du Pont de Chaume
Montauban, 82000
CLINIQUE du MILLENAIRE
Montpellier, 34960
Chu de Nancy - Hopital de Brabois
Nancy, 54511
CHU de NANTES - HOTEL DIEU
Nantes, 44093
Ap-Hp - Hopital Saint-Antoine
Paris, 75571
Chu de Bordeaux - Groupe Hospitalier Sud
Pessac, 33600
CHU de Rennes
Rennes, 35000
CHU de TOULOUSE - HOPITAL RANGUEIL
Toulouse, 31059
Clinique NCT+
Tours, 37042
CHU de TOURS - HOPITAL TROUSSEAU
Tours, 37044
About this study
The aim of this study is to improve the definition of the two main types of secondary tricuspid regurgitation.
- Conditions
- Remodeling, Cardiac, Tricuspid Regurgitation
- Being tested
- Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.Other
Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite criteria : cardiovascular death or unscheduled hospitalizations due to cardiovascular event.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start19 Jan 2017
- Primary completion25 Oct 2021
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remodeling, CardiacStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwan DONAL, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159923
- Sponsor's protocol ID
- 35RC16_8919_TRAP
- Acronym
- TRAP
- Status last verified
- Sep 2018
- First submitted
- 15 May 2017
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT03159923
- Acronym / sponsor ID
- TRAP / 35RC16_8919_TRAP
- Conditions
- Remodeling, Cardiac, Tricuspid Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 19 May 2017 (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 this study is to improve the definition of the two main types of secondary tricuspid regurgitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography, in patients stabilized.
Key inclusion criteria (3 listed)
- Any patients ≥ 18 years old, with moderate to severe tricuspid regurgitation (≥ 2/4), agreeing to participate ;
- The patients included can be ambulatory patients or stabilized hospitalised patients (meaning patient clinicaly stable, not decompensated, and whose normovolemia has been checked).
- Non opposition of the patient
Key exclusion criteria (8 listed)
- Patient whose accoustic window is judged by the operator as incompatible with a precise evaluation of the tricuspid regurgitation or anatomy of the right cavity ;
- TR < grade 2 ;
- TR secondary to primary pulmonary hypertension or congenital cardiopathy ;
- Primary tricuspid regurgitation (due to rheumatic heart disease, medication - included benfluorex, due to endocarditis, valvular prolapse, carcinoid syndrom or a cardiac stimulation lead …) ;
- Significant left heart valvulopathy (Mitral regurgitation > grade 2, Aortic insufficiency > grade 2, Mitral stenosis < 2 cm², Aortic stenosis < 1.5 cm²). A valvulopathy sucessfully operated isn't considered as an exclusion criteria;
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 |
|---|---|---|
| Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized. | Other | – |
Primary outcome
Composite criteria : cardiovascular death or unscheduled hospitalizations due to cardiovascular event.
Time frame: through study completion, an average of 1 year
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 12 Apr 2023.
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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.
Erwan DONAL, PhD principal investigator
Rennes University Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Remodeling, Cardiac and Tricuspid Regurgitation, run by Rennes University Hospital at 17 sites in France.
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 3 inclusion and 8 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. 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?
Composite criteria : cardiovascular death or unscheduled hospitalizations due to cardiovascular event. (time frame: through study completion, an average of 1 year). 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 12 Apr 2023.