Clinical Research in Cardiology

, Volume 99, Issue 2, pp 75–82

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

  • Otto Kamp
  • Marco Metra
  • Gilles W. De Keulenaer
  • Burkert Pieske
  • Viviane Conraads
  • José Zamorano
  • Lieven Huysse
  • Panos E. Vardas
  • Michael Böhm
  • Livio Dei Cas
Original Paper

DOI: 10.1007/s00392-009-0098-x

Cite this article as:
Kamp, O., Metra, M., De Keulenaer, G.W. et al. Clin Res Cardiol (2010) 99: 75. doi:10.1007/s00392-009-0098-x

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.

Keywords

HFPEF (heart failure preserved ejection fraction)6 MWTNebivololQuality of lifeELANDD

Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Otto Kamp
    • 1
  • Marco Metra
    • 2
  • Gilles W. De Keulenaer
    • 3
    • 4
  • Burkert Pieske
    • 5
  • Viviane Conraads
    • 6
  • José Zamorano
    • 7
  • Lieven Huysse
    • 8
  • Panos E. Vardas
    • 9
  • Michael Böhm
    • 10
  • Livio Dei Cas
    • 2
  1. 1.VU University Medical CenterAmsterdamThe Netherlands
  2. 2.Section of Cardiovascular Diseases, Department of Experimental and Applied MedicineUniversity of BresciaBresciaItaly
  3. 3.Department of PhysiologyUniversity of AntwerpAntwerpBelgium
  4. 4.Division of CardiologyMiddelheim HospitalAntwerpBelgium
  5. 5.Department of CardiologyMedical University GrazGrazAustria
  6. 6.University Hospital AntwerpEdegemBelgium
  7. 7.Hospital Clinico San CarlosMadridSpain
  8. 8.Medical DepartmentMenarini Benelux NV/SAZaventemBelgium
  9. 9.Department of CardiologyHeraklion University HospitalHeraklionGreece
  10. 10.Klinik für Innere Medizin IIIUniversitätsklinikum des SaarlandesHomburg/SaarGermany