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Regional differences in health-related quality of life in elderly heart failure patients: results from the CIBIS-ELD trial

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Abstract

Aim

Patient-reported outcomes such as health-related quality of life (HRQoL) are main treatment goals for heart failure (HF) and therefore endpoints in multinational therapy trials. However, little is known about country-specific differences in HRQoL and in treatment-associated HRQoL improvement. The present work sought to examine those questions.

Methods and results

We analysed data from the Cardiac Insufficiency Bisoprolol Study in Elderly (CIBIS-ELD) trial, in which patients from central and south-eastern Europe completed the HRQoL questionnaire SF-36 at baseline and the end of a 12-week beta-blocker up-titration (follow-up). 416 patients from Serbia (mean age 72.21 years, 69% NYHA-class I–II, 27.4% women) and 114 from Germany (mean age 73.64 years, 78.9% NYHA-class I–II, 47.4% women) were included. Controlling for clinical variables, the change in mental HRQoL from baseline to follow-up was modulated by Country: Serbian patients, M baseline = 37.85 vs. M follow−up = 40.99, t(526) = 5.34, p < .001, reported a stronger increase than Germans, M baseline = 37.66 vs. M follow−up = 38.23, t(526) = 0.68, ns. For physical HRQoL, we observed a main effect of Country, M Serbia = 39.28 vs. M Germany = 35.29, t(526) = 4.24, p < .001.

Conclusion

We observed significant differences in HF patients from Germany and Serbia and country-specific differences between Serbian and German patients in mean physical HRQoL. Changes in mental HRQoL were modulated by country. Those results may reflect psychological, sociocultural, aetiological differences or regional differences in phenotype prevalence. More importantly, they suggest that future multinational trials should consider such aspects when designing a trial in order to avoid uncertainties aligned to data interpretation and to improve subsequent treatment optimisation.

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Notes

  1. As in previous analyses with the whole sample [16], there were no significant main or interaction effects for beta-blocker agent (bisoprolol vs. carvedilol) or pre-treatment with beta-blocker (pre-treatment vs. no pre-treatment) on HRQoL in the subsamples included here. Thus, we dropped agent and pre-treatment with beta-blocker from the subsequent model.

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Acknowledgements

The CIBIS-ELD trial was supported by the Competence Network of Heart Failure funded by the Federal Ministry of Education and Research (BMBF, Project Number BMBF01GI0205) and is registered with Number ISRCTN34827306 at http://www.controlled-trials.com. Merck KGaA supported the trial with an unrestricted research grant without any rights to influence trial design, data collection, data analysis, and interpretation or publication of the results and thus did not interfere with the investigators’ intellectual property rights. We are indebted to the patients who participated in the study.

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Authors and Affiliations

  1. Department of Psychosomatic Medicine and Psychotherapy, University of Göttingen Medical Centre, Göttingen, Germany

    Mira-Lynn Chavanon & Christoph Herrmann-Lingen

  2. German Centre for Cardiovascular Research DZHK, Partner Site Göttingen, Göttingen, Germany

    Mira-Lynn Chavanon & Christoph Herrmann-Lingen

  3. Department of Internal Medicine—Cardiology, Charité University Medicine Berlin, Berlin, Germany

    Simone Inkrot, Christine Zelenak, Elvis Tahirovic, Jovan Veskovic, Burkert Pieske & Hans-Dirk Düngen

  4. German Centre for Cardiovascular Research DZHK, Partner Site Berlin, Berlin, Germany

    Elvis Tahirovic, Jovan Veskovic, Burkert Pieske & Hans-Dirk Düngen

  5. Clinic for Cardiovascular Diseases, Clinical Centre Nis, University of Niš, Niš, Serbia

    Dragana Stanojevic & Svetlana Apostolovic

  6. Department of Cardiology, University Hospital Centre ‘Dr Dragisa Misovic-Dedinje’, Belgrade, Serbia

    Aleksandra Sljivic

  7. School of Medicine, University of Belgrade, Belgrade, Serbia

    Aleksandra Sljivic, Arsen D. Ristic, Dragan Matic & Goran Loncar

  8. Department of Cardiology, Clinical Centre of Serbia, Belgrade, Serbia

    Arsen D. Ristic

  9. Emergency Department, Clinical Center of Serbia, Belgrade, Serbia

    Dragan Matic

  10. Department of Cardiology, Clinical Hospital Zvezdara, Belgrade, Serbia

    Goran Loncar

  11. Department of Cardiology, University Hospital Medical Center Bezanijska Kosa, Belgrade, Serbia

    Marija Zdravkovic

  12. Department of Internal Medicine, General Hospital Murska Sobota and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

    Mitja Lainscak

  13. Department of Psychology, Philipps-Universität Marburg, Gutenbergstraße 18, 35032, Marburg, Germany

    Mira-Lynn Chavanon

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  1. Mira-Lynn Chavanon
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  15. Christoph Herrmann-Lingen
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  16. Hans-Dirk Düngen
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Corresponding author

Correspondence to Mira-Lynn Chavanon.

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Conflict of interest

PD. Dr. Düngen received grants from Merck KGaA, equipment provision support from Merk KGaA, Roche, and Biosite during the conduct of the study. Prof. Dr. Herrmann-Lingen reports grants from German Ministry for Research Education and Research, grants from German Research Foundation, personal fees from Hans Huber Publishers, personal fees from Pfizer, personal fees from Heel, outside the submitted work. All remaining authors have nothing to declare.

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Chavanon, ML., Inkrot, S., Zelenak, C. et al. Regional differences in health-related quality of life in elderly heart failure patients: results from the CIBIS-ELD trial. Clin Res Cardiol 106, 645–655 (2017). https://doi.org/10.1007/s00392-017-1101-6

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  • DOI: https://doi.org/10.1007/s00392-017-1101-6

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