Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction

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.

Conditions

• Functional Tricuspid Regurgitation

Interventions

DIAGNOSTIC_TEST

Transthoracic Echocardiography

All patients undergo physical examination, ECG, Transthoracic Echocardiography, six minutes walking test and blood sample (natruretic peptides, renal and liver function)

Sponsors & Collaborators

• Cardarelli Hospital

  collaborator OTHER

• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

  collaborator OTHER_GOV

• Monaldi Hospital

  collaborator OTHER

• Federico II University

  collaborator OTHER

• Cava de Tirreni Costiera Amalfitana Hospital Salerno

  collaborator UNKNOWN

• Umberto I Hospital, Nocera Inferiore

  collaborator OTHER

• Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

  collaborator OTHER

• Azienda Ospedaliera S. Maria della Misericordia

  collaborator OTHER

• University of Pisa

  collaborator OTHER

• Niguarda Hospital

  collaborator OTHER

• IRCCS Policlinico S. Donato

  collaborator OTHER

• University of Parma

  collaborator OTHER

• University of Siena

  collaborator OTHER

• Foligno Hospital

  collaborator OTHER

• University of Targu Mures, Romania

  collaborator OTHER

• Szeged University

  collaborator OTHER

• National Cardiology Hospital, Bulgaria

  collaborator OTHER

• Bieganski Hospital Lodz, Poland

  collaborator UNKNOWN

• Departement of clinical sciences, Lund University and Skane University Hospidal, Lund Sweden

  collaborator UNKNOWN

• King Faisal Specialist Hospital & Research Center

  collaborator OTHER

• Piedmont Heart Institute, Inc., Atlanta, GA

  collaborator INDUSTRY

• Jewish General Hospital

  collaborator OTHER

• Ospedali Riuniti di Foggia

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-11

Primary Completion

2023-12-01

Completion

2024-12-01

Countries

• Italy

Study Locations