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

NCT05209919 | Unknown

• 1 other identifier: 0099915/21
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Tricuspid Regurgitation

Keywords

tricuspid regurgitation; heart failure

Outcome Measures

Primary Outcomes (1)

• Time to all-cause death or to first HF hospitalization

  12 months

Study Arms (4)

Pulmonary arterial hypertension

All patients with pulmonary arterial hypertension and significant functional tricuspid regurgitation

Diagnostic Test: Transthoracic Echocardiography

HFrEF

All patients with HFrEF and significant functional tricuspid regurgitation

Diagnostic Test: Transthoracic Echocardiography

HFpEF

All patients with HFpEF and significant functional tricuspid regurgitation

Diagnostic Test: Transthoracic Echocardiography

Heart Failure mildly-reduced ejection fraction

All patients with Heart Failure mildly-reduced ejection fraction and significant functional tricuspid regurgitation

Diagnostic Test: Transthoracic Echocardiography

Interventions

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)

Also known as: six minutes walking test, Physical Examination, 12-lead electrocardiogram, blood sample test

HFpEF; HFrEF; Heart Failure mildly-reduced ejection fraction; Pulmonary arterial hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Foundation IRCCS SanMatteo Hospital

Pavia, PV, 27100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 36445668 DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Failure

Interventions

Echocardiography; Physical Examination; Electrocardiography

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 27, 2022
• Study Start: November 11, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)