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Browsing by Author "Kosevic, Dragana (15071017200)"

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    Cardio-microcurrent device for chronic heart failure: first-in-human clinical study
    (2021)
    Kosevic, Dragana (15071017200)
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    Wiedemann, Dominik (26639916000)
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    Vukovic, Petar (35584122100)
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    Ristic, Velibor (35491539000)
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    Riebandt, Julia (55840122100)
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    Radak, Una (57221966988)
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    Brandes, Kersten (7003943088)
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    Goettel, Peter (57203765875)
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    Duengen, Hans-Dirk (35332227300)
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    Tahirovic, Elvis (24339336300)
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    Kottmann, Tatjana (57189696360)
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    Voss, Hans Werner (57225324802)
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    Zdravkovic, Marija (24924016800)
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    Putnik, Svetozar (16550571800)
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    Schmitto, Jan D. (57219444826)
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    Mueller, Johannes (7404870968)
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    Rame, Jesus Eduardo (6603350865)
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    Peric, Miodrag (7006618529)
    Aims: Most devices for treating ambulatory Class II and III heart failure are linked to electrical pulses. However, a steady electric potential gradient is also necessary for appropriate myocardial performance and may be disturbed by structural heart diseases. We investigated whether chronic application of electrical microcurrent to the heart is feasible and safe and improves cardiac performance. The results of this study should provide guidance for the design of a two-arm, randomized, controlled Phase II trial. Methods and results: This single-arm, non-randomized pilot study involved 10 patients (9 men; mean age, 62 ± 12 years) at two sites with 6 month follow-up. All patients had New York Heart Association (NYHA) Class III heart failure and non-ischaemic dilated cardiomyopathy, with left ventricular ejection fraction (LVEF) <35%. A device was surgically placed to deliver a constant microcurrent to the heart. The following tests were performed at baseline, at hospital discharge, and at six time points during follow-up: determination of LVEF and left ventricular end-diastolic/end-systolic diameter by echocardiography; the 6 min walk test; and assessment of NYHA classification and quality of life (36-Item Short-Form Health Survey questionnaire). Microcurrent application was feasible and safe; no device-related or treatment-related adverse events occurred. During follow-up, rapid and significant signal of efficacy (P < 0.005) was present with improvements in LVEF, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and distance walked. For eight patients, NYHA classification improved from Class III to Class I (for seven, as early as 14 days post-operatively); for one, to Class II; and for one, to Class II/III. 36-Item Short-Form Health Survey questionnaire scores also improved highly significantly. Conclusions: Chronic application of microcurrent to the heart is feasible and safe and leads to a rapid and lasting improvement in heart function and a near normalization of heart size within days. The NYHA classification and quality of life improve just as rapidly. © 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
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    Depression, anxiety, and quality of life as predictors of rehospitalization in patients with chronic heart failure
    (2023)
    Veskovic, Jovan (56951285600)
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    Cvetkovic, Mina (59571521900)
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    Tahirovic, Elvis (24339336300)
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    Zdravkovic, Marija (24924016800)
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    Apostolovic, Svetlana (13610076800)
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    Kosevic, Dragana (15071017200)
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    Loncar, Goran (55427750700)
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    Obradovic, Danilo (35731962400)
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    Matic, Dragan (25959220100)
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    Ignjatovic, Aleksandra (54395417600)
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    Cvetkovic, Tatjana (57211064383)
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    Posch, Maximilian G. (35307873000)
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    Radenovic, Sara (57000170900)
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    Ristić, Arsen D. (7003835406)
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    Dokic, Danilo (58670130200)
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    Milošević, Nenad (58669174900)
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    Panic, Natasa (58670130300)
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    Düngen, Hans-Dirk (16024171900)
    Background: Chronic heart failure (CHF) is a severe condition, often co-occurring with depression and anxiety, that strongly affects the quality of life (QoL) in some patients. Conversely, depressive and anxiety symptoms are associated with a 2–3 fold increase in mortality risk and were shown to act independently of typical risk factors in CHF progression. The aim of this study was to examine the impact of depression, anxiety, and QoL on the occurrence of rehospitalization within one year after discharge in CHF patients. Methods: 148 CHF patients were enrolled in a 10-center, prospective, observational study. All patients completed two questionnaires, the Hospital Anxiety and Depression Scale (HADS) and the Questionnaire Short Form Health Survey 36 (SF-36) at discharge timepoint. Results: It was found that demographic and clinical characteristics are not associated with rehospitalization. Still, the levels of depression correlated with gender (p ≤ 0.027) and marital status (p ≤ 0.001), while the anxiety values ​​were dependent on the occurrence of chronic obstructive pulmonary disease (COPD). However, levels of depression (HADS-Depression) and anxiety (HADS-Anxiety) did not correlate with the risk of rehospitalization. Univariate logistic regression analysis results showed that rehospitalized patients had significantly lower levels of Bodily pain (BP, p = 0.014), Vitality (VT, p = 0.005), Social Functioning (SF, p = 0.007), and General Health (GH, p = 0.002). In the multivariate model, poor GH (OR 0.966, p = 0.005) remained a significant risk factor for rehospitalization, and poor General Health is singled out as the most reliable prognostic parameter for rehospitalization (AUC = 0.665, P = 0.002). Conclusion: Taken together, our results suggest that QoL assessment complements clinical prognostic markers to identify CHF patients at high risk for adverse events. Clinical Trial Registration: The study is registered under http://clinicaltrials.gov (NCT01501981, first posted on 30/12/2011), sponsored by Charité – Universitätsmedizin Berlin. © 2023, The Author(s).
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    DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure (DIGIT-HF): Baseline characteristics compared to recent randomized controlled heart failure trials
    (2025)
    Bavendiek, Udo (6603181145)
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    Thomas, Nele Henrike (57462387700)
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    Berliner, Dominik (35763672200)
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    Liu, Xiaofei (57194779909)
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    Schwab, Johannes (7103000098)
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    Rieth, Andreas (56671124800)
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    Maier, Lars S. (7006758541)
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    Schallhorn, Sven (57208665843)
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    Angelini, Eleonora (57208630137)
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    Soltani, Samira (57221604303)
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    Rathje, Fabian (57196454880)
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    Sandu, Mircea-Andrei (59522326400)
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    Geller, Welf (57219306461)
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    Gaspar, Thomas (35242589300)
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    Hambrecht, Rainer (55270627500)
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    Zdravkovic, Marija (24924016800)
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    Philipp, Sebastian (7005290672)
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    Kosevic, Dragana (15071017200)
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    Nickenig, Georg (55618199500)
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    Scheiber, Daniel (57188684210)
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    Winkler, Sebastian (35761822300)
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    Becher, Peter Moritz (25025631600)
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    Lurz, Philipp (35810676500)
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    Hülsmann, Martin (7006719269)
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    von Karpowitz, Maria (57218118768)
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    Schröder, Christoph (57196280792)
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    Neuhaus, Barbara (57204459000)
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    Seltmann, Anika (59522013000)
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    von der Leyen, Heiko (6604097968)
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    Veltmann, Christian (8866550200)
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    Störk, Stefan (6603842450)
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    Böhm, Michael (35392235500)
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    Koch, Armin (7403037285)
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    Großhennig, Anika (26025890500)
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    Bauersachs, Johann (7004626054)
    Aims: This report presents the baseline characteristics of patients enrolled in the DIGIT-HF trial and compares them with participants from recent trials with improved outcomes in patients with heart failure (HF) and a reduced ejection fraction (HFrEF). Methods and results: DIGIT-HF, a randomized, double-blind, placebo-controlled, multicentre trial enrolling patients with symptomatic HFrEF (New York Heart Association [NYHA] functional class II and left ventricular ejection fraction [LVEF] ≤30%, or NYHA class III–IV and LVEF ≤40%), compares the efficacy and safety of digitoxin versus placebo in addition to standard treatment. Most baseline characteristics of the intention-to-treat population (1212 patients, mean age 66 ± 11 years, 20% women, mean LVEF 29 ± 7%) were similar to those in recent HFrEF trials. The distribution of NYHA class II, III, and IV was 30%, 66% and 4%, respectively, and indicates that the patients were sicker than in comparator HFrEF trials. Less patients had atrial fibrillation (27%) than those in recent HFrEF trials, but prescription rates of background therapy with beta-blockers (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor–neprilysin inhibitors (95%), mineralocorticoid receptor antagonists (76%), and diuretics (87%) were high and similar. Overall, 40% of patients were on angiotensin receptor–neprilysin inhibitors, 19% on sodium–glucose cotransporter 2 inhibitors, and 9% on ivabradine. Rates of implantable cardioverter-defibrillator (ICD, 64%) and cardiac resynchronization therapy (CRT, 25%) devices were much higher than in recent HFrEF trials. Conclusions: Patients included in DIGIT-HF display a more severe HF symptom burden and higher rates of ICD/CRT implants compared to participants in recent HFrEF trials, while pharmacotherapy was largely similar. Clinical Trial Registration: EudraCT (2013–005326-38). © 2025 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
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    Radial artery vs saphenous vein graft used as the second conduit for surgical myocardial revascularization: Long-term clinical follow-up
    (2015)
    Petrovic, Ivana (35563660900)
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    Nezic, Dusko (6701705512)
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    Peric, Miodrag (7006618529)
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    Milojevic, Predrag (6602755452)
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    Djokic, Olivera (57035697600)
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    Kosevic, Dragana (15071017200)
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    Tasic, Nebojsa (6603322581)
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    Djukanovic, Bosko (6507409280)
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    Otasevic, Petar (55927970400)
    Background: There is ongoing debate regarding the efficacy of the radial artery (RA) as an aortocoronary conduit, with few solid data regarding long-term clinical results. We sought to determine if the use of the RA as the second arterial conduit, beside left internal thoracic artery (LITA), would improve long-term clinical outcome after CABG as compared to saphenous vein graft (SVG). Methods: Between March 2001 and November 2003, 200 patients underwent isolated CABG and were randomized in 1:1 fashion to receive either LITA and RA grafts or LITA and SVGs. The primary end point was composite of cardiovascular mortality, non-fatal myocardial infarction and need for repeat myocardial revascularization (either surgical or percutaneous). Results: There was no significant difference in absolute survival, with 12 deaths in each group during the study period (log rank = 0.01, p = 0.979). There were 3 and 2 cardiac deaths in RA and SVG groups, respectively. There was no difference in long-term clinical outcome between the groups (log rank = 0.450, p = 0.509). Eleven patients in RA group had one or more non-fatal events; 7 patients suffered a myocardial infarction, 9 patients underwent percutaneous coronary angioplasty, and 1 patient required redo coronary surgery. Likewise, 13 patients in SVG group had non-fatal event; 7 patients had myocardial infarction, 13 patients had percutaneous coronary intervention and 3 patients required redo coronary surgery. Angiograms were performed in 23 patients in RA group (patency rate 92%) and 24 in SVG group (patency rate 86%) (p = 0.67). Conclusion: In this small randomised study our data indicate that there is no difference in the 8year clinical outcomes in relatively young patients between those having a RA or a saphenous vein graft used as a second conduit, beside LITA, for surgical myocardial revascularisation. © 2015 Petrovic et al.

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