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| Name | Class |
|---|---|
| Cardarelli Hospital | OTHER |
| Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy | OTHER_GOV |
| Monaldi Hospital | OTHER |
| Federico II University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary arterial hypertension | All patients with pulmonary arterial hypertension and significant functional tricuspid regurgitation |
| |
| HFrEF | All patients with HFrEF and significant functional tricuspid regurgitation |
| |
| HFpEF | All patients with HFpEF and significant functional tricuspid regurgitation |
| |
| Heart Failure mildly-reduced ejection fraction | All patients with Heart Failure mildly-reduced ejection fraction and significant functional tricuspid regurgitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transthoracic Echocardiography | Diagnostic Test | All patients undergo physical examination, ECG, Transthoracic Echocardiography, six minutes walking test and blood sample (natruretic peptides, renal and liver function) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to all-cause death or to first HF hospitalization | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation IRCCS SanMatteo Hospital | Recruiting | Pavia | PV | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36445668 | Derived | Ghio S, Bossone E, Mercurio V, Rudski L, Vannan M; RIGHT-NET Investigators. Echocardiographic assessment and clinical implication of functional tricuspid regurgitation in heart failure with reduced or preserved ejection fraction (ECLIPSE-HF) : Rationale and design of the study. Int J Cardiovasc Imaging. 2022 Dec;38(12):2581-2591. doi: 10.1007/s10554-022-02599-8. Epub 2022 Aug 8. |
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| OTHER |
| Cava de Tirreni Costiera Amalfitana Hospital Salerno | UNKNOWN |
| Umberto I Hospital, Nocera Inferiore | OTHER |
| Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona | OTHER |
| Azienda Ospedaliera S. Maria della Misericordia | OTHER |
| University of Pisa | OTHER |
| Niguarda Hospital | OTHER |
| IRCCS Policlinico S. Donato | OTHER |
| University of Parma | OTHER |
| University of Siena | OTHER |
| Foligno Hospital | OTHER |
| University of Targu Mures, Romania | OTHER |
| Szeged University | OTHER |
| National Cardiology Hospital, Bulgaria | OTHER |
| Bieganski Hospital Lodz, Poland | UNKNOWN |
| Departement of clinical sciences, Lund University and Skane University Hospidal, Lund Sweden | UNKNOWN |
| King Faisal Specialist Hospital & Research Center | OTHER |
| Piedmont Heart Institute, Inc., Atlanta, GA | INDUSTRY |
| Jewish General Hospital | OTHER |
| Ospedali Riuniti di Foggia | OTHER |
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|
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D010808 | Physical Examination |
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004568 | Electrodiagnosis |
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