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Effect of the long-term administration of nebivolol on clinical symptoms, exercise capacity and left ventricular function in patients with heart failure and preserved left ventricular ejection fraction: background, aims and design of the ELANDD study

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Abstract

Background

The SENIORS trial demonstrated that nebivolol has beneficial effects in patients with heart failure. However, the role of beta-blocker therapy in patients with heart failure and preserved left ventricular ejection fraction (HFPEF) is still unsettled.

Objective

To assess the long-term effects of administration of nebivolol, compared to placebo, on the clinical symptoms, exercise capacity and parameters of left ventricular (LV) function in patients with HFPEF.

Methods

The Effect of Long-term Administration of Nebivolol on clinical symptoms, exercise capacity and left ventricular function in patients with Diastolic Dysfunction (ELANDD) study is a prospective multicenter European trial in 120 patients with HFPEF randomised to nebivolol or placebo. HFPEF is defined as symptoms or signs of heart failure, a LV ejection fraction >45% and evidence of diastolic LV dysfunction by Doppler echocardiography. Procedures include a baseline clinical examination, 6-min walk test (6MWT), electrocardiography, Doppler echocardiography and Minnesota QoL questionnaire. Nebivolol or placebo is started at 2.5 mg/day and gradually uptitrated to 10 mg/day. After initiation of the study, patients are assessed at 1, 2, 5 and 6 weeks (titration phase) and at weeks 12 and 26. The primary endpoint is the change from baseline in the 6MWT distance with nebivolol versus placebo. Sample size calculations are based on an anticipated 15% difference (70 m) in the 6MWT distance between nebivolol and placebo-treated patients. This study will allow the collection of data regarding the possible clinical benefits and the effects on LV function of nebivolol administration in patients with HFPEF.

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Acknowledgments

The study is supported by Menarini International Medical Department (Firenze, Italy).

Author information

Authors and Affiliations

  1. VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands

    Otto Kamp

  2. Section of Cardiovascular Diseases, Department of Experimental and Applied Medicine, University of Brescia, c/o Spedali Civili. P. le Spedali Civili 1, 25123, Brescia, Italy

    Marco Metra & Livio Dei Cas

  3. Department of Physiology, University of Antwerp, Antwerp, Belgium

    Gilles W. De Keulenaer

  4. Division of Cardiology, Middelheim Hospital, Antwerp, Belgium

    Gilles W. De Keulenaer

  5. Department of Cardiology, Medical University Graz, Auenbruggerplatz 15, 8036, Graz, Austria

    Burkert Pieske

  6. University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Belgium

    Viviane Conraads

  7. Hospital Clinico San Carlos, Prof. Martín Lagos S/N, 28040, Madrid, Spain

    José Zamorano

  8. Medical Department, Menarini Benelux NV/SA, Belgicastraat 4, 1930, Zaventem, Belgium

    Lieven Huysse

  9. Department of Cardiology, Heraklion University Hospital, PO Box 1352, Stavrakia, Heraklion, Crete, 71110, Greece

    Panos E. Vardas

  10. Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Kirrberger Strasse, 66421, Homburg/Saar, Germany

    Michael Böhm

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  1. Otto Kamp
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Corresponding author

Correspondence to Marco Metra.

Additional information

For the ELANDD investigators.

Appendix

Appendix

ELANDD investigators

M. Metra, Brescia, Italy; O. Kamp, Amsterdam, The Netherlands; V. Conraads, Antwerp, Belgium; G. de Keulenaer, Antwerp, Belgium, J. L. Zamorano, Madrid, Spain; J. D. Alves, Lisbon, Portugal; H. Kragten, Heerlen, The Netherlands; P. Vardas, Heraklion, Greece, M. Goethals, Aalst, Belgium; B. Pieske, Gottingen, Germany; R. Schwinger, Weiden, Germany; M. Bohm; Homburg, Germany.

Steering committee

M. Metra, Brescia, Italy; O. Kamp, Amsterdam; B. Pieske, Graz, Austria; M. Thomson, Brussels, Belgium.

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Kamp, O., Metra, M., De Keulenaer, G.W. et al. Effect of the long-term administration of nebivolol on clinical symptoms, exercise capacity and left ventricular function in patients with heart failure and preserved left ventricular ejection fraction: background, aims and design of the ELANDD study. Clin Res Cardiol 99, 75–82 (2010). https://doi.org/10.1007/s00392-009-0098-x

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