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Published on: June 10, 2025
Regional differences among female patients with heart failure from the Cardiac Insufficiency BIsoprolol Study in
Svetlana Apostolovic, Dragana Stanojevic1, Mitja Lainscak
1Clinic for cardiovascular diseases, Clinical Center Nis, Serbia. draganastanojevic1@gmail.com.
Insights
Regional differences in heart failure (HF) among women were observed in etiology, comorbidities, and treatment, despite similar risk factors. These disparities highlight the need for tailored clinical trial designs, especially for underrepresented female populations.
Area of Science:
- Cardiology
- Clinical Trials
- Epidemiology
Background:
- Heart failure (HF) affects women differently across regions.
- The Cardiac Insufficiency BIsoprolol Study in ELDerly (CIBIS-ELD) trial provides data on elderly HF patients.
- Understanding regional variations in female HF patients is crucial.
Purpose of the Study:
- To investigate regional disparities in demographics, etiology, risk factors, comorbidities, and treatment of female HF patients within the CIBIS-ELD trial.
- To compare female HF patients from Germany and Southeastern Europe.
Main Methods:
- Subanalysis of the CIBIS-ELD clinical trial data.
- Inclusion of 159 female patients from Germany and 169 from Southeastern Europe.
- Comparison of demographic, etiological, comorbidity, and treatment data between the two regions.
Main Results:
- Significant differences in HF etiology (hypertension in Germany, coronary artery disease in SE Europe) and ejection fraction (preserved in Germany, reduced in SE Europe).
- Higher prevalence of depression, COPD, and malignancies in German patients; lower glomerular filtration rate in SE European patients.
- Variations in medication use, with SE European patients receiving more ACE inhibitors and loop diuretics, and fewer ARBs and MRAs.
Conclusions:
- Despite similar cardiovascular risk factors, significant regional differences exist in HF etiology, comorbidities, and treatment among women.
- These findings underscore the importance of considering regional variations in clinical trial design and implementation.
- Addressing the underrepresentation of women in large clinical trials is essential.
Background:
The aim of our study was to examine regional differences in the demographics, etiology, risk factors, comorbidities and treatment of female patients with heart failure (HF) in the Cardiac Insufficiency BIsoprolol Study in ELDerly (CIBIS-ELD) clinical trial.
Methods And Results:
One hundred and fifty-nine female patients from Germany and 169 from Southeastern (SE) Europe (Serbia, Slovenia and Montenegro) were included in this subanalysis of the CIBIS-ELD trial. Women comprised 54% of the study population in Germany and 29% in SE Europe. German patients were significantly older. The leading cause of HF was arterial hypertension in German patients, 71.7% of whom had a preserved ejection fraction. The leading etiology in SE Europe was the coronary artery disease; 67.6% of these patients had a reduced left ventricular ejection fraction (34.64 ± 7.75%). No significant differences were found in the prevalence of traditional cardiovascular risk factors between the two regions (hypertension, diabetes, hypercholesterolemia, smoking and family history of myocardial infarction). Depression, chronic obstructive pulmonary disease and malignancies were the comorbidities that were noted more frequently in the German patients, while the patients from SE Europe had a lower glomerular filtration rate. Compared with the German HF patients, the females in SE Europe received significantly more angiotensin converting enzyme inhibitors, loop diuretics and less frequently angiotensin receptor blockers and mineralocorticoid receptor antagonists.
Conclusions:
Significant regional differences were noted in the etiology, comorbidities and treatment of female patients with HF despite similar risk factors. Such differences should be considered in the design and implementation of future clinical trials, especially as women remain underrepresented in large trial populations.
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