Clinical trial NCT03159923: Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation
Official title: Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Remodeling, Cardiac
Tricuspid Regurgitation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography, in patients stabilized.

Brief summary: The aim of this study is to improve the definition of the two main types of secondary tricuspid regurgitation.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Composite criteria : cardiovascular death or unscheduled hospitalizations due to cardiovascular event.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens-Picardie - Site Sud
city: Créteil
country: France
facility: Ap-Hp - Hopital Henri Mondor
city: Dijon
country: France
facility: CHU de DIJON - HOPITAL FRANCOIS MITTERAND
city: Grenoble
country: France
facility: Chu Grenoble - Michallon
city: Lomme
country: France
facility: Ghicl - Hopital Saint Philibert
city: Marseille
country: France
facility: Chu Marseille - Hopital Nord
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Montauban
country: France
facility: Clinique Du Pont de Chaume
city: Montpellier
country: France
facility: CLINIQUE du MILLENAIRE
city: Nancy
country: France
facility: Chu de Nancy - Hopital de Brabois
city: Nantes
country: France
facility: CHU de NANTES - HOTEL DIEU
city: Paris
country: France
facility: Ap-Hp - Hopital Saint-Antoine
city: Pessac
country: France
facility: Chu de Bordeaux - Groupe Hospitalier Sud
city: Rennes
country: France
facility: CHU de Rennes
city: Toulouse
country: France
facility: CHU de TOULOUSE - HOPITAL RANGUEIL
city: Tours
country: France
facility: Clinique NCT+
city: Tours
country: France
facility: CHU de TOURS - HOPITAL TROUSSEAU
Study officials:
affiliation: Rennes University Hospital
name: Erwan DONAL, PhD
role: PRINCIPAL_INVESTIGATOR
References: