Original article
Determinants of Change in Quality of Life in the Cardiac Insufficiency Bisoprolol Study in Elderly (CIBIS-ELD)

https://doi.org/10.1016/j.ejim.2013.01.003Get rights and content

Abstract

Objective

Little is known about parameters that lead to improvement in QoL in individual patients. We analysed the data of the Cardiac Insufficiency Bisoprolol Study in Elderly (CIBIS-ELD) in order to answer the question of how and to what extent change in health-related QoL during up-titration with bisoprolol vs. carvedilol is influenced by clinical and psychosocial factors in elderly patients with heart failure.

Methods

This is a QoL analysis of CIBIS-ELD, an investigator-initiated multi-center randomised phase III trial in elderly patients (65 years or older) with moderate to severe heart failure. Clinical parameters such as New York Heart Association functional class, heart rate, left ventricular ejection fraction (LVEF), 6-min walk distance, as well as the physical and psychosocial component scores on the short-form QoL health survey (SF36) and depression were recorded at baseline and at the final study visit.

Results

Full baseline and follow-up QoL data were available for 589 patients (292 in the bisoprolol and 297 in the carvedilol group). Mean physical and psychosocial QoL improved significantly during treatment. In regression analyses, changes in both SF36 component scores from baseline to follow-up were mainly predicted by baseline QoL and depression as well as change in depression over time. Changes in cardiac severity markers were significantly weaker predictors.

Conclusion

Mean QoL increased during up-titration of bisoprolol and carvedilol. Both baseline depression and improvement in depression over time are associated with greater improvement in QoL more strongly than changes in cardiac severity measures.

Introduction

Chronic heart failure results from different cardiac pathologies including coronary heart disease, hypertension, and others. It occurs in around 2% of the adult population, in 8% of over 75 year olds and in 15% of those over 85 years [1]. As Europe will experience a considerable increase in the number of senior citizens over the next decades, the prevalence of heart failure is also expected to increase. Particularly in this elderly patient population, when breathlessness and resultant immobility become increasingly severe, quality of life (QoL) is a clinically important issue.

The presence of heart failure impacts on perceived quality of life more substantially than many other conditions [2]. Moreover, quality of life in patients with heart failure is closely associated with mortality [3] and admission [4] to hospital. Also, depression and anxiety are common in these patients and considerably influence their QoL [5]. Prevalences of depression in heart failure patients have been reported from 15% to 36%, which is clearly above a life time prevalence of 13% for major depression in the general population [6].

Previous research has reported on associations between depression and QoL in heart failure patients. Such cross sectional associations (e.g. [7]) might be simply due to a symptom overlap of the constructs of QoL and depression. It is still unclear if there is an independent effect of depression on future QoL after controlling for QoL at baseline. Thus, the causal direction of that association remains unclear until this question is addressed in the context of a longitudinal study. A longitudinal study offers the opportunity to analyse predictive associations between depression, objective parameters of physical function and QoL. It also allows quantifying the relative importance of depression and biomedical factors for changes in QoL.

Several medical interventions and drug treatments have been shown to improve QoL in heart failure patients. In our randomised comparison trial on the tolerability of up-titration of two beta-blockers (Cardiac Insufficiency Bisoprolol Study in Elderly; CIBIS-ELD), QoL scores as well as clinical severity markers such as New York Heart Association functional class (NYHA), left ventricular ejection fraction, and 6-min walk test distance improved over the course of the treatment [8]. There were no differences between the two beta-blocker (BB) groups regarding the improvement in QoL.

In the analysis presented here, it was our aim to identify predictors of future QoL from both baseline characteristics and changes during BB up-titration. We investigated how and to what extent the changes in health-related QoL observed during BB up-titration are influenced by clinical and psychosocial factors in elderly patients with heart failure. Thereby we specifically focused on relative contributions of psychosocial and biomedical factors to change in QoL.

Section snippets

Study design

This investigator-initiated multi-center, randomised, parallel, double-dummy, double-blind group trial compared the tolerability of bisoprolol and carvedilol in elderly patients with heart failure. The trial was performed in 21 centers in Germany, 1 in Montenegro, 15 in Serbia and 4 in Slovenia. Detailed design and main results have been published elsewhere [8], [9]. The CIBIS-ELD protocol was approved by all relevant federal institutes for drugs and medical devices as well as by the national

Sample Characteristics

In total, 434 patients were randomised to bisoprolol and 449 to carvedilol. Seven patients withdrew their consent and had to be excluded. Full baseline and follow-up QoL data were available for 589 of the remaining 876 patients. Of these, 292 were in the bisoprolol and 297 in the carvedilol group (see Fig. 1). The mean age was about 73 years, and more than three-fifths of the patients were male (Table 1). The flow through the study is described elsewhere [9]. In comparison with patients

Main findings

In this subanalysis of the Cardiac Insufficiency Bisoprolol Study in Elderly, there was a general improvement in all dimensions of QoL from baseline to follow-up. After adjustment for baseline QoL, low baseline depression and improvements in depression scores were the strongest independent predictors of improvement in both physical and psychosocial QoL. Interestingly, the effect of depression was significantly stronger than effects of objective biomedical factors. This applied not only to

Learning points

  • Little is known about parameters that lead to improvement in QoL in individual patients.

  • In patients with heart failure, mean quality of life (QoL) increases during up-titration of bisoprolol and carvedilol and better improvement in clinical severity and depression is associated with greater improvement in QoL.

  • In general, patients with poor initial QoL are most likely to benefit from treatment.

Conflicts of interests

We declare that we have no conflicts of interests.

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    Grant support: This trial was supported by the Competence Network of Heart Failure funded by the Federal Ministry of Education and Research (BMBF, project number 01GI0205) and is registered with number ISRCTN34827306 at www.controlledtrials.com.

    1

    The authors contributed equally.

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