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

Functional Tricuspid Regurgitation Clinical Trial

— ECLIPSE-HF  

Official title:

Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction (ECLIPSE-HF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209919
• Other study ID #: 0099915/21
• Status: Recruiting
• Start date: November 11, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2022
• Source: Foundation IRCCS San Matteo Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Functional Tricuspid Regurgitation
• Heart Failure
• Tricuspid Valve Insufficiency

Intervention

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)

Locations

Country	Name	City	State
Italy	Foundation IRCCS SanMatteo Hospital	Pavia	PV

Sponsors (24)

Lead Sponsor

Collaborator

Foundation IRCCS San Matteo Hospital

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Azienda Ospedaliera S. Maria della Misericordia, Bieganski Hospital Lodz, Poland, Cardarelli Hospital, Cava de Tirreni Costiera Amalfitana Hospital Salerno, Departement of clinical sciences, Lund University and Skane University Hospidal, Lund Sweden, Federico II University, Foligno Hospital, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, IRCCS Policlinico S. Donato, Jewish General Hospital, king Faisal Hospital Riyad, Saudi Arabia, Monaldi Hospital, National Cardiology Hospital, Bulgaria, Niguarda Hospital, Ospedali Riuniti di Foggia, Piedmont Heart Institute, Inc., Atlanta, GA, Szeged University, Umberto I Hospital, Nocera Inferiore, University of Parma, University of Pisa, University of Siena, University of Targu Mures, Romania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to all-cause death or to first HF hospitalization		12 months