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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Tricuspid Regurgitation
• Intervention / Treatment: Diagnostic test: Transthoracic Echocardiography

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy, 27100
      • Recruiting
      • Foundation IRCCS SanMatteo Hospital
      • Contact: Stefano Ghio, PI; Phone Number: 0382501326; Email: s.ghio@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonary arterial hypertension; All patients with pulmonary arterial hypertension and significant functional tricuspid regurgitation	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); Other Names: 12-lead electrocardiogram; six minutes walking test; Physical Examination; blood sample test
HFrEF; All patients with HFrEF and significant functional tricuspid regurgitation	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); Other Names: 12-lead electrocardiogram; six minutes walking test; Physical Examination; blood sample test
HFpEF; All patients with HFpEF and significant functional tricuspid regurgitation	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); Other Names: 12-lead electrocardiogram; six minutes walking test; Physical Examination; blood sample test
Heart Failure mildly-reduced ejection fraction; All patients with Heart Failure mildly-reduced ejection fraction and significant functional tricuspid regurgitation	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); Other Names: 12-lead electrocardiogram; six minutes walking test; Physical Examination; blood sample test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to all-cause death or to first HF hospitalization	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2021
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 22, 2022
• First Posted (ACTUAL): January 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 22, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: tricuspid regurgitation; heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Failure; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 0099915/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No