Clinical trial NCT05209919: Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction
Official title: Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction (ECLIPSE-HF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Tricuspid Regurgitation
Keywords: tricuspid regurgitation; heart failure
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: Cardarelli Hospital
name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
name: Monaldi Hospital
name: Federico II University
name: Cava de Tirreni Costiera Amalfitana Hospital Salerno
name: Umberto I Hospital, Nocera Inferiore
name: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
name: Azienda Ospedaliera S. Maria della Misericordia
name: University of Pisa
name: Niguarda Hospital
name: IRCCS Policlinico S. Donato
name: University of Parma
name: University of Siena
name: Foligno Hospital
name: University of Targu Mures, Romania
name: Szeged University
name: National Cardiology Hospital, Bulgaria
name: Bieganski Hospital Lodz, Poland
name: Departement of clinical sciences, Lund University and Skane University Hospidal, Lund Sweden
name: King Faisal Specialist Hospital & Research Center
name: Piedmont Heart Institute, Inc., Atlanta, GA
name: Jewish General Hospital
name: Ospedali Riuniti di Foggia
First posted: 2022-01-27
Enrollment: 400
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 to be enrolled are 300 with heart failure and 100 with PAH, given that each center guarantees the enrollment of a minimum number of 20 patients.

Brief summary: Purpose Functional tricuspid regurgitation (FTR) has been shown to be associated with increased morbidity and mortality in several clinical conditions, including heart failure (HF) with reduced left ventricular ejection fraction as well as pulmonary arterial hypertension (PAH). We have designed a study aiming at: characterizing the echocardiographic morphology of the tricuspid valve apparatus and the pathophysiology of FTR in heart failure with reduced, mid-range or preserved left ventricular ejection fraction (HFrEF, HFmrEF, HFpEF) and in PAH patients; correlating the morphologic characteristics of tricuspid valve apparatus with hemodynamic severity of FTR; correlating the severity of FTR with the clinical condition and outcome. Methods The study will be a non-interventional, prospective, international, multicenter, longitudinal study. The minimum number of patients which are expected to be enrolled is 300 HF patients, including HFrEF, HFmrEF and HFpEF patients, whereas 100 PAH patients will serve as control. The patients will be enrolled in 20 centers in Europe, North America and Saudi Arabia. The echocardiographic parameters will be analyzed by the local investigators; a quality control committee will evaluate all data entered in the database to identify potential outliers and a random sample of 10% of cases will be blindly re-analysed in a central core-lab. Conclusions This study has been designed to improve our understanding of pathophysiological mechanisms and clinical relevance of FTR across all HF phenotypes. The results could potentially allow a more appropriate selection of heart failure patients with FTR for tricuspid valve intervention by percutaneous or surgical repair or replacement.


Eligibility criteria: Inclusion Criteria:

* consecutive consenting outpatients with HFrEF, HFmrHF, HFpEF or PAH,
* ambulatory visit routinely planned with an echocardiographic examination,
* at the time of the visit at least moderate FTR diagnosed at echocardiography (by visual assessment),
* aged ≥ 18 years old,
* capable to sign an informed consent.

Exclusion Criteria:

* age \< 18 years old,
* congenital heart disease,
* heart failure due to organic mitral or aortic valve disease. No examination will be performed in addition to what is routinely planned for patients' evaluation.

Primary outcomes:
measure: Time to all-cause death or to first HF hospitalization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Foundation IRCCS SanMatteo Hospital
state: PV
Study officials:
References: