Skip to main content

Advertisement

SpringerLink
Log in

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

  • Original Paper
  • Published:
The International Journal of Cardiovascular Imaging Aims and scope Submit manuscript

Abstract

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 (ClinicalTrials.gov Identifier NCT05209919). 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. Standard echocardiographic parameters will be analyzed by local investigators; strain measurements will be performed in a single 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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Nath J, Foster E, Heidenreich PA Impact of tricuspid regurgitation on long-term survival. J Am Coll Cardiol (2004) Feb 4;43(3):405–9

  2. Benfari G, Antoine C, Miller WL, Thapa P, Topilsky Y, Rossi A, Michelena HI, Pislaru S, Enriquez-Sarano M (2019) Excess Mortality Associated With Functional Tricuspid Regurgitation Complicating Heart Failure With Reduced Ejection Fraction. Circulation 140:196–206

    Article  CAS  PubMed  Google Scholar 

  3. Prihadi EA, Delgado V, Leon MB, Enriquez-Sarano M, Topilsky Y, Bax JJ (2019) Morphologic Types of Tricuspid Regurgitation: Characteristics and Prognostic Implications. JACC Cardiovasc Imaging 12:491–499

    Article  PubMed  Google Scholar 

  4. Dietz MF, Prihadi EA, van der Bijl P, Goedemans L, Mertens BJA, Gursoy E, van Genderen OS, Ajmone Marsan N, Delgado V, Bax JJ (2019) Prognostic Implications of Right Ventricular Remodeling and Function in Patients With Significant Secondary Tricuspid Regurgitation. Circulation 140:836–845

    Article  PubMed  Google Scholar 

  5. Ghio S, Mercurio V, Fortuni F, Forfia PR, Gall H, Ghofrani A, Mathai SC, Mazurek JA, Mukherjee M, Richter M, Scelsi L, Hassoun PM, Tello K (2020) A comprehensive echocardiographic method for risk stratification in pulmonary arterial hypertension. Eur Respir J 56(3):2000513 TAPSE in PAH investigators

    Article  PubMed  Google Scholar 

  6. Prapan N, Ratanasit N, Karaketklang K (2020) Significant functional tricuspid regurgitation portends poor outcomes in patients with atrial fibrillation and preserved left ventricular ejection fraction. BMC Cardiovasc Disord 20(1):433

    Article  PubMed  PubMed Central  Google Scholar 

  7. Bohbot Y, Chadha G, Delabre J, Landemaine T, Beyls C, Tribouilloy C (2019) Characteristics and prognosis of patients with significant tricuspid regurgitation. Arch Cardiovasc Dis 112:604–614

    Article  PubMed  Google Scholar 

  8. Hahn RT, Asch F, Weissman NJ, Grayburn P, Kar S, Lim S, Ben-Yehuda O, Shahim B, Chen S, Liu M, Redfors B, Medvedofsky D, Puri R, Kapadia S, Sannino A, Lindenfeld J, Abraham WT, Mack MJ, Stone GW (2020) Impact of Tricuspid Regurgitation on Clinical Outcomes: The COAPT Trial. J Am Coll Cardiol 76:1305–1314

    Article  CAS  PubMed  Google Scholar 

  9. Di Mauro M, Lorusso R, Parolari A, Ravaux JM, Bonalumi G, Guarracini S, Ricci F, Benedetto U Calafiore AM 2021 The best approach for functional tricuspid regurgitation: A network meta-analysis.J Card Surg36:2072–2080

  10. Asmarats L, Puri R, Latib A, Navia JL, Rodés-Cabau J (2018) Transcatheter Tricuspid Valve Interventions: Landscape, Challenges, and Future Directions. J Am Coll Cardiol 71:2935–2956

    Article  PubMed  Google Scholar 

  11. Taramasso M, Benfari G, van der Bijl P, Alessandrini H, Attinger-Toller A, Biasco L, Lurz P, Braun D, Brochet E, Connelly KA, de Bruijn S, Denti P, Deuschl F, Estevez-Loureiro R, Fam N, Frerker C, Gavazzoni M, Hausleiter J, Ho E, Juliard JM, Kaple R, Besler C, Kodali S, Kreidel F, Kuck KH, Latib A, Lauten A, Monivas V, Mehr M, Muntané-Carol G, Nazif T, Nickening G, Pedrazzini G, Philippon F, Pozzoli A, Praz F, Puri R, Rodés-Cabau J, Schäfer U, Schofer J, Sievert H, Tang GHL, Thiele H, Topilsky Y, Rommel KP, Delgado V, Vahanian A, Von Bardeleben RS, Webb JG, Weber M, Windecker S, Winkel M, Zuber M, Leon MB, Hahn RT, Bax JJ, Maisano F (2019) Transcatheter Versus Medical Treatment of Patients With Symptomatic Severe Tricuspid Regurgitation. J Am Coll Cardiol 74:2998–3008

  12. Prihadi EA, van der Bijl P, Dietz M, Abou R, Vollema EM, Marsan NA, Delgado V, Bax JJ (2019) Prognostic Implications of Right Ventricular Free Wall Longitudinal Strain in Patients With Significant Functional Tricuspid Regurgitation. Circ Cardiovasc Imaging 12(3):e008666

    Article  PubMed  Google Scholar 

  13. Fortuni F, Hirasawa K, Bax JJ, Delgado V, Ajmone Marsan N (2021) Multi-Modality Imaging for Interventions in Tricuspid Valve Disease. Front Cardiovasc Med 8:638487

    Article  PubMed  PubMed Central  Google Scholar 

  14. Fortuni F, Marques AI, Bax JJ, Ajmone Marsan N, Delgado V (2020) Echocardiography-computed tomography fusion imaging for guidance of transcatheter tricuspid valve annuloplasty. Eur Heart J Cardiovasc Imaging 21:937–938

    Article  PubMed  Google Scholar 

  15. Agricola E, Asmarats L, Maisano F, Cavalcante JL, Liu S, Milla F, Meduri C, Rodés-Cabau J, Vannan M, Pibarot P (2021) Imaging for Tricuspid Valve Repair and Replacement. JACC Cardiovasc Imaging 14:61–111

    Article  PubMed  Google Scholar 

  16. Guta AC, Badano LP, Tomaselli M, Mihalcea D, Bartos D, Parati G, Muraru D (2021) The Pathophysiological Link between Right Atrial Remodeling and Functional Tricuspid Regurgitation in Patients with Atrial Fibrillation: A Three-Dimensional Echocardiography Study. J Am Soc Echocardiogr 34:585–594

    Article  PubMed  Google Scholar 

  17. Badano LP, Hahn R, Rodríguez-Zanella H, Araiza Garaygordobil D, Ochoa-Jimenez RC, Muraru D (2019) Morphological Assessment of the Tricuspid Apparatus and Grading Regurgitation Severity in Patients With Functional Tricuspid Regurgitation: Thinking Outside the Box. JACC Cardiovasc Imaging 12:652–664

    Article  PubMed  Google Scholar 

  18. McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Böhm M, Burri H, Butler J, Čelutkienė J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A, ESC Scientific Document Group ; 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure.Eur Heart J Aug27:ehab368

  19. Galiè N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M, ESC Scientific Document Group ; 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT).Eur Heart J37:67–119

  20. Klinger JR, Elliott CG, Levine DJ, Bossone E, Duvall L, Fagan K, Frantsve-Hawley J, Kawut SM, Ryan JJ, Rosenzweig EB, Sederstrom N, Steen VD Badesch DB 2019 Therapy for Pulmonary Arterial Hypertension in Adults: Update of the CHEST Guideline and Expert Panel Report.Chest155:565–586

  21. Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB (2010) Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr 23:685–788

    Article  PubMed  Google Scholar 

  22. Zoghbi WA, Adams D, Bonow RO et al Recommendations for noninvasive evaluation of native valvular regurgitation: a report from the American Society of Echocardiography developed in collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr 2017:303–71

  23. Guazzi M, Bandera F, Pelissero G, Castelvecchio S, Menicanti L, Ghio S, Temporelli PL, Arena R (2013) Tricuspid annular plane systolic excursion and pulmonary arterial systolic pressure relationship in heart failure: an index of right ventricular contractile function and prognosis. Am J Physiol Heart Circ Physiol 305(9):H1373–H1381

    Article  CAS  PubMed  Google Scholar 

  24. Aduen JF, Castello R, Daniels JT, Diaz JA, Safford RE, Heckman MG, Crook JE, Burger CD (2011) Accuracy and precision of three echocardiographic methods for estimating mean pulmonary artery pressure. Chest 139:347–352

    Article  PubMed  Google Scholar 

  25. Carluccio E, Biagioli P, Lauciello R, Zuchi C, Mengoni A, Bardelli G, Alunni G, Gronda EG, Ambrosio G (2019) Superior Prognostic Value of Right Ventricular Free Wall Compared to Global Longitudinal Strain in Patients With Heart Failure. J Am Soc Echocardiogr 32:836–844e1

    Article  PubMed  Google Scholar 

  26. Muraru D, Spadotto V, Cecchetto A, Romeo G, Aruta P, Ermacora D, Jenei C, Cucchini U, Iliceto S, Badano LP (2016) Validation with Cardiac Magnetic Resonance and Comparison with the Previous Analysis Tool. Eur Heart J Cardiovasc Imaging 17:1279–1289New Speckle-Tracking Algorithm for Right Ventricular Volume Analysis from Three- Dimensional Echocardiographic Data Sets:

  27. Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU (2015) Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr 28:1–39e14

    Article  PubMed  Google Scholar 

  28. Ferrara F, Gargani L, Contaldi C, Agoston G, Argiento P, Armstrong WF, Bandera F, Cademartiri F, Citro R, Cittadini A, Cocchia R, D’Alto M, D’Andrea A, Douschan P, Ghio S, Grünig E, Guazzi M, Guida S, Kasprzak JD, Kolias TJ, Limongelli G, Marra AM, Mazzola M, Mauro C, Moreo A, Pieri F, Pratali L, Pugliese NR, Raciti M, Ranieri B, Rudski L, Saggar R, Salzano A, Serra W, Stanziola AA, Vannan M, Voilliot D, Vriz O, Wierzbowska-Drabik K, Naeije R, Bossone E, RIGHT Heart International NETwork (RIGHT-NET) Investigators (2021) ;. A multicentric quality-control study of exercise Doppler echocardiography of the right heart and the pulmonary circulation. The RIGHT Heart International NETwork (RIGHT-NET). Cardiovasc Ultrasound 19(1):9

  29. Fortuni F, Dietz MF, Prihadi EA, van der Bijl P, De Ferrari GM, Knuuti J, Bax JJ, Delgado V, Marsan NA (2021) Prognostic Implications of a Novel Algorithm to Grade Secondary Tricuspid Regurgitation. JACC Cardiovasc Imaging 14:1085–1095

    Article  PubMed  Google Scholar 

  30. Ghio S, Guazzi M, Scardovi AB, Klersy C, Clemenza F, Carluccio E, Temporelli PL, Rossi A, Faggiano P, Traversi E, Vriz O, Dini FL, all investigators (2017) Different correlates but similar prognostic implications for right ventricular dysfunction in heart failure patients with reduced or preserved ejection fraction. Eur J Heart Fail 19:873–887

    Article  CAS  PubMed  Google Scholar 

  31. Guazzi M, Ghio S, Adir Y (2020) Pulmonary Hypertension in HFpEF and HFrEF: JACC Review Topic of the Week. J Am Coll Cardiol 76:1102–1111

    Article  PubMed  Google Scholar 

  32. Vonk Noordegraaf A, Chin KM, Haddad F, Hassoun PM, Hemnes AR, Hopkins SR, Kawut SM, Langleben D, Lumens J, Naeije R (2019) Pathophysiology of the right ventricle and of the pulmonary circulation in pulmonary hypertension: an update. Eur Respir J 24(1):1801900

    Article  Google Scholar 

Download references

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Author information

Authors and Affiliations

  1. Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

    Stefano Ghio MD

  2. U.O.C. Cardiologia Riabilitativa Cardarelli, Napoli, Italy

    Eduardo Bossone MD

  3. Dipartimento di Scienze Mediche Traslazionali, Università Federico II, Napoli, Italy

    Valentina Mercurio MD

  4. Piedmont Heart Institute, Atlanta, Georgia, USA

    Lawrence Rudski MD

  5. Jewish General Hospital, McGill University, Montréal, Canada

    Mani Vannan MD

Authors
  1. Stefano Ghio MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Eduardo Bossone MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Valentina Mercurio MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Lawrence Rudski MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Mani Vannan MD
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

RIGHT-NET Investigators

Contributions

All authors contributed to the study conception and design. The first draft of the manuscript was written by Stefano Ghio and all authors and investigators commented on previous versions of the manuscript. All authors and all investigators read and approved the final manuscript.

Corresponding author

Correspondence to Stefano Ghio MD.

Ethics declarations

Conflict of interest

The authors have no relevant financial or non-financial interests to disclose.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Appendix 1

Appendix 1

RIGHT Heart International NETwork (RIGHT-NET) Investigators: Policlinico S. Matteo Hospital, Pavia I: Stefano Ghio, Laura Scelsi, Alessandra Greco, Annalisa Turco, Giandomenico Disabato, Gianluigi Guida, Andrea Attanasio. U.O.C. Cardiologia Riabilitativa Cardarelli, Napoli, I: Eduardo Bossone, Rosangela Cocchia, Andrea Salzano, Marianna Conte, Ciro Mauro. Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, I: Luna Gargani. Monaldi Hospital, Napoli, I: Michele D’Alto, Simona Sperlongano, Gemma Salerno, Paola Argiento, Emanuele Romeo. Università degli Studi di Napoli Federico II, Dipartimento di Medicina Interna, Napoli, I: Antonio Cittadini. Università degli Studi di Napoli Federico II, Cardiologia Riabilitativa, Napoli, I: Nino De Luca, Ciro Santoro. Università degli Studi di Napoli Federico II, Napoli, I; Dipartimento di Scienze Mediche Traslazionali, Università degli Studi di Napoli Federico II, Napoli, I: Valentina Mercurio, Carlo Gabriele Tocchetti. Ospedale Cava de’ Tirreni- Costiera Amalfitana, Salerno, I: Francesco Ferrara. Ospedale di Nocera Inferiore, Salerno, I: Antonello D’Andrea. AOU San Giovanni di Dio e Ruggi d’Aragona Salerno, I. Rodolfo Citro. Azienda Ospedaliero-Universitaria di Foggia, Foggia, I: Michele Correale, Martino Fortunato, Lucia Tricarico. Università e Azienda Ospedaliera Santa Maria della Misericordia, Perugia, I: Erberto Carluccio, Rosanna Lauciello. Azienda Ospedaliero Universitaria Pisana, Pisa, I: Nicola Riccardo Pugliese. Ospedale Metropolitano Niguarda, Milano, I: Antonella Moreo, Francesca Casadei, Benedetta De Chiara. IRCCS Policlinico San Donato, Milano, I: Francesco Bandera. Azienda Ospedaliero-Universitaria di Parma, I: Walter Serra. Azienda Ospedaliera Universitaria Senese, Siena, I: Alberto Palazzuoli. Ospedale San Giovanni Battista, Foligno: Federico Fortuni. University of Târgu-Mureş, Romania. Istvan Adorjan. University of Szeged, Szeged, Hungary: Albert Varga, Gergely Agoston. National Cardiology Hospital, Sofia, Bulgaria: Krasimira Hristova.

Bieganski Hospital, Medical University of Lodz, Poland: Jaroslaw D. Kasprzak. Department of Clinical Sciences, Lund University and Skåne University Hospital, Lund, Sweden: Ellen Ostenfeld. King Faisal Hospital, Riyad, Saudi Arabia: Olga Vriz, Talal Alzahrani. Piedmont Heart Institute, Atlanta, Georgia, USA: Sara Mobasseri, Mani Vannan. Jewish General Hospital, McGill University, Montréal, Canada: Lawrence Rudski.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Ghio, S., Bossone, E., Mercurio, V. et al. Echocardiographic assessment and clinical implication of functional tricuspid regurgitation in heart failure with reduced or preserved ejection fraction (ECLIPSE-HF). Int J Cardiovasc Imaging 38, 2581–2591 (2022). https://doi.org/10.1007/s10554-022-02599-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10554-022-02599-8

Search

Navigation