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Öğe Comparison of clinical characteristics of patients with heart failure and preserved ejection fraction with atrial fibrillation versus sinus rhythm: Insights from the APOLLON registry(2020) Özlek, Bülent; Özlek, Eda; Tekinalp, Mehmet; Kahraman, Serkan; Zencirkiran, Hicaz; Başaran, Özcan; Biteker, MuratObjective: The aim of this study was to assess the clinical characteristics of patients with heart failure and preserved ejection fraction (HFpEF) and atrial fibrillation (AF) and compare them with those of HFpEF patients without AF. Methods: This study was a sub-group analysis of a multicenter, observational, and cross-sectional registry conducted in Turkey (ClinicalTrials.gov identifier: NCT03026114). Patients with HFpEF were divided into 2 groups: HFpEF with AF and HFpEF with sinus rhythm (SR), and the clinical characteristics of the groups were compared. Results: In a total of 819 HFpEF patients (median age: 67 years; 58% women), 313 (38.2%) had AF. Compared to the patients with SR, those with AF were older (70 years vs 66 years; p<0.001) and more symptomatic, with a higher rate of classification as New York Heart Association functional class III-IV, paroxysmal nocturnal dyspnea, orthopnea, palpitations, fatigue, pulmonary crepitations, and peripheral edema. The hospitalization rate for heart failure was higher (28.4% vs 12.6%; p<0.001) in patients with AF, and participants with AF had higher level of N-terminal pro-B-type natriuretic peptide (887 pg/mL vs 394.8 pg/mL; p<0.001) and higher left atrial volume index level. Patients without AF had a higher burden of diabetes mellitus, obstructive sleep apnea, and coronary artery disease. The prescription rate of nondihydropyridine calcium blockers, digoxin, loop diuretics, and anticoagulant drugs was higher in the AF group. Conclusion: The results of this study revealed that in a large Turkish cohort with HFpEF, significant clinical differences were present between those with and without AF and. Further prospective studies are needed to clarify the prognostic implications of AF in this growing heart failure population in our country.Öğe Design and rationale for the ASSOS study: appropriateness of aspirin use in medical outpatients a multicenter and observational study(Turkish Society of Cardiology, 2018) Çelik, Oğuzhan; Çil, Cem; Özlek, Bülent; Özlek, Eda; Doğan, Volkan; Başaran, Özcan; Demirci, Erkan; Bekar, Lütfü; Kalçık, Macit; Karaarslan, Osman; Yetim, Mücahit; Doğan, Tolga; Demir, Vahit; Kalkan, Sedat; Özkan, Buğra; Hidayet, Şıho; Taylan, Gökhan; Küçüksu, Zafer; Çelik, Yunus; Efe, Süleyman Çağan; Aslan, Onur; Biteker, MuratObjective: The aim of this study was to describe the current status of aspirin use and the demographic characteristics of patients on aspirin for primary and secondary prevention of cardiovascular diseases. Methods: The Appropriateness of Aspirin Use in Medical Outpatients: A Multicenter, Observational Study (ASSOS) trial was a multicenter, cross-sectional, and observational study conducted in Turkey. The study was planned to include 5000 patients from 14 cities in Turkey. The data were collected at one visit, and the current clinical practice regarding aspirin use was evaluated (ClinicalTrials.gov number NCT03387384). Results: The study enrolled all consecutive patients who were admitted to the outpatient cardiology clinics from March 2018 until June 2018. Patients should be at least 18 years old, have signed written informed consent, and on aspirin (80–325 mg) therapy within the last 30 days. Cardiologists from the hospital participates in the study. Patients were divided into 2 categories according to presence or absence of atherosclerotic cardiovascular disease, namely secondary prevention group and primary prevention group, respectively. The appropriate use of aspirin in the primary and secondary prevention groups was assessed according to the European Society of Cardiology guidelines and US Preventive Services Task Force. The patients’ gastrointestinal bleeding risk factors and colorectal cancer risk were evaluated. Conclusion: The ASSOS registry will be the most comprehensive and largest study in Turkey evaluating the appropriateness of aspirin use. The results of this study help understand the potential misuse of aspirin in a real-world setting. © 2018 by Turkish Society of Cardiology.Öğe Gender disparities in heart failure with mid-range and preserved ejection fraction: Results from APOLLON study(2019) Özlek, Bülent; Özlek, Eda; Kahraman, Serkan; Tekinalp, Mehmet; Zencirkıran Ağuş, Hicaz; Çelik, Oğuzhan; Biteker, MuratObjective: This study aimed to examine gender-based differences in epidemiology, clinical characteristics, and management of consecutive patients with heart failure with mid-range ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF). Methods: The APOLLON trial (A comPrehensive, ObservationaL registry of heart faiLure with mid-range and preserved ejection fractiON) is a multicenter, cross-sectional, and observational study. Consecutive patients with HFmrEF or HFpEF who were admitted to the cardiology clinics were included (NCT03026114). Herein, we performed a post-hoc analysis of data from the APOLLON trial. Results: The study population included 1065 (mean age of 67.1±10.6 years, 54% women) patients from 11 sites in Turkey. Compared with men, women were older (68 years vs. 67 years, p<0.001), had higher body mass index (29 kg/m2 vs. 27 kg/m2 , p<0.001), and had higher heart rate (80 bpm vs. 77.5 bpm, p<0.001). Women were more likely to have HFpEF (82% vs. 70.9%, p<0.001), and they differ from men having a higher prevalence of hypertension (78.7% vs. 73.2%, p=0.035) and atrial fibrillation (40.7% vs. 29.9%, p<0.001) but lower prevalence of coronary artery disease (29.5% vs. 54.9%, p<0.001). Women had higher N-terminal pro-B-type natriuretic peptide (691 pg/mL vs. 541 pg/mL, p=0.004), lower hemoglobin (12.7 g/dL vs. 13.8 g/dL, p<0.001), and serum ferritin (51 ng/mL vs. 64 ng/mL, p=0.001) levels, and they had worse diastolic function (E/e'=10 vs. 9, p<0.001). The main cause of heart failure (HF) in women was atrial fibrillation, while it was ischemic heart disease in men. Conclusion: Clinical characteristics, laboratory findings, and etiological factors are significantly different in female and male patients with HFmrEF and HFpEF. This study offers a broad perspective for increased awareness about this patient profile in Turkey. (Anatol J Cardiol 2019; 21: 242-52)Öğe Geographical Variations in Patients with Heart Failure and Preserved Ejection Fraction: A Sub-Group Analysis of the APOLLON Registry(2019) Özlek, Bülent; Özlek, Eda; Aguş, Hicaz Zencirkıran; Tekinalp, Mehmet; Kahraman, Serkan; Çelik, Oğuzhan; Biteker, MuratBackground: Clinical characteristics of patients with heart failure may vary geographically. However, limited data are available regarding the geographical differences of patients with heart failure and preserved ejection fraction. Aims: The present subgroup analysis aims to investigate the geographical differences in clinical characteristics, management, and primary etiology of patients with heart failure and preserved ejection fraction in Turkey. Study Design: A cross-sectional study. Methods: A comPrehensive, ObservationaL registry of heart faiLure with mid-range and preserved ejection fractiON (APOLLON) is a multicenter and observational study conducted in seven regions of Turkey (NCT03026114). The present study is a post-hoc analysis of the APOLLON registry. In this substudy, we compared the clinical characteristics of 819 consecutive patients with heart failure and preserved ejection fraction (mean age, 67 years; 57.8% women) admitted to cardiology outpatient units in different geographical regions. Results: Based on the geographical distribution of the entire Turkish population, the highest number of patients enrolled were from Marmara (271 patients, 33.1%). All demographical characteristics, clinical and laboratory findings, comorbidities, primary etiology, and medications prescribed were significantly different between the regions. Furthermore, inter-regional gender differences were identified. Comparatively, the Aegean and Mediterranean regions had older patients with heart failure and preserved ejection fraction (p<0.001), and the Black Sea, Southeast, and East Anatolia regions had predominantly male patients (51.2, 54.5, and 56.9%, respectively; p=0.002). Notably, the Mediterranean and Southeast Anatolia had more symptomatic patients, and history of hospitalization for heart failure was more prevalent in Southeast Anatolia (33.3%, p<0.001). Prevalence of atrial fibrillation was higher in the Mediterranean and Southeast Anatolia regions (51 and 48.5%, p<0.001), and patients with heart failure and preserved ejection fraction had a higher prevalence of hypertension in the Mediterranean, Southeast Anatolia, and Black Sea regions (p=0.002). Angiotensin-converting enzyme inhibitors were more frequently prescribed in East Anatolia (52.3%, p=0.001), and the prevalence of patients with heart failure and preserved ejection fraction using loop diuretics (48.8%, p=0.003) was higher in the Black Sea region. Conclusion: This study was the first to show geographical differences in clinical characteristics of patients with heart failure and preserved ejection fraction in Turkey. Determination of the clinical characteristics of the heart failure and preserved ejection fraction population based on the geographical region may enables physicians to adopt a region-specific clinical approach toward heart failure and preserved ejection fraction.Öğe Inappropriate Use of Aspirin in Real-Life Cardiology Practice: Results from the Appropriateness of Aspirin Use in Medical Outpatients: A Multicenter, Observational Study (ASSOS) Study(Aves, 2021) Celik, Oguzhan; Cil, Cem; Basaran, Ozcan; Demirci, Erkan; Tanik, Veysel Ozan; Altuntas, Emine; Biteker, MuratBackground: Indications and appropriateness of aspirin use have not been well investigated in Turkey. Aims: To investigate the prescription patterns and appropriateness of aspirin in a real-world clinical setting. Study Design: Cross-sectional study. Methods: The Appropriateness of Aspirin Use in Medical Outpatients: A Multicenter, Observational Study (ASSOS) is a cross-sectional and multicenter study that included 5007 consecutive patients aged 18 or over who presented to 30 different cardiology outpatient clinics from 14 cities throughout Turkey. Only patients using aspirin (80-325 mg) were included. The study population was divided into 2 groups regarding the use of aspirin: primary prevention (PP) group and secondary prevention (SP) group. The indication of aspirin use was evaluated following the 2016 European Society of Cardiology (ESC) and the 2016 United States Preventative Services Task Force (USPTF) guidelines in the PP group. Results: A total of 5007 patients (mean age 62.15 +/- 11.05, 39% female) were enrolled. The PP group included 1132 (22.6%) patients, and the SP group included 3875 (77.4%) patients. Of the 1132 patients, inappropriate use of aspirin was determined in 100% of the patients according to the ESC guidelines, and 71% of the patients according to the USPTF guidelines. Multivariate logistic regression analysis showed age OR: 0.98 CI (0.97-0.99) P=.037, smoking OR: 0.60 CI (0.44- 0.82) P=.001, heart failure OR: 2.11 CI (1.14-3.92) P=.017, hypertension OR: 0.51 CI (0.36-0.74) P<.001, diabetes mellitus OR: 0.34 CI (0.25-0.47) P<.001, oral anticoagulant use OR: 3.01 CI (1.10-8.25) P=.032, and female sex OR: 2.73 CI (1.96-3.80) P<.001 were independent predictors of inappropriate aspirin use in PP patients. Conclusion: Although there are considerable differences between the USPTF and the ESC guidelines with respect to recommendations for aspirin use in PP, inappropriate use of aspirin in Turkey is frequent in real-world practice for both guidelines. Besides, heart failure, oral anticoagulant use, and the female sex of the patients were independent predictors of inappropriate use of aspirin.Öğe Rationale, design, and methodology of the APOLLON trial: a comPrehensive, observational registry of heart failure with mid-range and preserved ejectioN fraction(Turkish Society of Cardiology, 2018) Özlek, Bülent; Özlek, Eda; Çelik, Oğuzhan; Çil, Cem; Doğan, Volkan; Tekinalp, Mehmet; Zencirkıran Ağuş, Hicaz; Kahraman, Serkan; Ösken, Altuğ; Rencüzoğulları, İbrahim; Tanık, Veysel Ozan; Bekar, Lütfü; Çakır, Mustafa Ozan; Kaya, Bedri Caner; Tibilli, Hakan; Çelik, Yunus; Başaran, Özcan; Mert, Kadir Uğur; Sevinç, Samet; Demirci, Erkan; Dondurmacı, Engin; Biteker, MuratObjective: Although almost half of chronic heart failure (HF) patients have mid-range (HFmrEF) and preserved left-ventricular ejection fraction (HFpEF), no studies have been carried out with these patients in our country. This study aims to determine the demographic characteristics and current status of the clinical background of HFmrEF and HFpEF patients in a multicenter trial. Methods: A comPrehensive, ObservationaL registry of heart faiLure with mid-range and preserved ejectiON fraction (APOLLON) trial will be an observational, multicenter, and noninterventional study conducted in Turkey. The study population will include 1065 patients from 12 sites in Turkey. All data will be collected at one point in time and the current clinical practice will be evaluated (ClinicalTrials.gov number NCT03026114). Results: We will enroll all consecutive patients admitted to the cardiology clinics who were at least 18 years of age and had New York Heart Association class II, III, or IV HF, elevated brain natriuretic peptide levels within the last 30 days, and an left ventricular ejection fraction (LVEF) of at least 40%. Patients fulfilling the exclusion criteria will not be included in the study. Patients will be stratified into two categories according to LVEF: mid-range EF (HFmrEF, LVEF 40%-49%) and preserved EF (HFpEF, LVEF ?50%). Regional quota sampling will be performed to ensure that the sample was representative of the Turkish population. Demographic, lifestyle, medical, and therapeutic data will be collected by this specific survey. Conclusion: The APOLLON trial will be the largest and most comprehensive study in Turkey evaluating HF patients with a LVEF ?40% and will also be the first study to specifically analyze the recently designated HFmrEF category. © 2018 by Turkish Society of Cardiology.Öğe Rationale, design, and methodology of the EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study(2019) Özlek, Eda; Çekiç, Edip Güvenç; Özlek, Bülent; Çil, Cem; Çelik, Oğuzhan; Doğan, Volkan; Biteker, MuratObjective: The aim of this study is to assess the prevalence of polypharmacy, inappropriate drug use, and drug-drug interactions (DDIs) in elderly patients presenting at outpatient cardiology clinics in Turkey. Methods: The EPIC (Epidemiology of Polypharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study will be an observational, real-world, multicenter study conducted to evaluate DDIs and polypharmacy in elderly cardiac outpatients. All consecutive patients (aged ?65 years) admitted to outpatient cardiology clinics between July 30, 2018 and July 30, 2019 who provide written, informed consent will be enrolled. A total of approximately 5000 patients are to be enrolled in this non-interventional study. All of the data will be collected at one point in time and current clinical practice will be evaluated (ClinicalTrials.gov NCT03370523). Results: Patient demographics, comorbid disease characteristics, laboratory test results, and details of medication use will be collected using self-reports and medical records. The severity of comorbid disease will be recorded and scored according to Charlson Comorbidity Index (CCI) and patients will be divided into 3 groups: mild, those with a CCI score of 1–2; moderate, those with a CCI score of 3–4; and severe, those with a CCI score of ?5. Polypharmacy will be defined as the use of 5 or more medications at one time. DDIs will be determined using the Lexicomp Online drug interaction screening tool and potentially inappropriate medications will be defined based on the 2015 update of the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Severe drug interactions will be defined as those in category D or X. Conclusion: EPIC will be the first large-scale study in Turkey to evaluate polypharmacy, potentially inappropriate medications, and DDIs in elderly cardiac outpatients in a real-world clinical setting.
