Wiener klinische Wochenschrift
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Wien. Klin. Wochenschr. · Dec 2016
Randomized Controlled Trial Multicenter StudyEvaluation of the pharmacoDYNAMIC effects of riociguat in subjects with pulmonary hypertension and heart failure with preserved ejection fraction : Study protocol for a randomized controlled trial.
The presence of pulmonary hypertension (PH) severely aggravates the clinical course of heart failure with preserved ejection fraction (HFPEF) resulting in substantial morbidity and mortality. So far, neither established heart failure therapies nor pulmonary vasodilators have proven to be effective for this condition. Riociguat (Adempas®, BAY 63-2521), a stimulator of soluble guanylate cyclase, is a novel pulmonary and systemic vasodilator that has been approved for the treatment of precapillary forms of PH. With regard to postcapillary PH, the DILATE-1 study was a multicenter, double-blind, randomized, placebo-controlled single-dose study in subjects with PH associated with HFPEF. Although there was no significant change in the primary outcome measure, peak decrease in mean pulmonary artery pressure with riociguat versus placebo, riociguat significantly increased stroke volume without changing heart rate, pulmonary artery wedge pressure, transpulmonary pressure gradient or pulmonary vascular resistance. The present study is designed to test the efficacy of long-term treatment with riociguat in patients with PH associated with HFPEF. ⋯ The DYNAMIC study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical phase IIb trial evaluating the efficacy, safety and kinetics of riociguat in PH-HFPEF patients. The drug will be given over 26 weeks to evaluate the effects of riociguat versus placebo. The primary efficacy variable will be the change from baseline in cardiac output at rest, measured by right heart catheter after 26 weeks of study drug treatment. Additional efficacy variables will be changes from baseline in further hemodynamic parameters, changes in left and right atrial area, right ventricular volume, as well as right ventricular ejection fraction measured by cardiac magnetic resonance imaging, and changes from baseline in World Health Organization (WHO) class and N‑terminal prohormone B‑type natriuretic peptide (NT-proBNP). The trial was registered on 25 August 2014 (EudraCT Number: 2014-003055-60; www.clinicaltrialsregister.eu ).
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Wien. Klin. Wochenschr. · Dec 2016
Can circulating M30 and M65 levels be beneficial markers in the diagnosis and management of patients with complete hydatidiform mole?
The objective of this study is to evaluate the prognostic value of M30 and M65 levels as markers of apoptotic activity and maternal serum oxidative stress in patients with complete hydatidiform mole (CHM). ⋯ Our results indicated that oxidative stress and apoptosis may play significant roles in CHM development. In addition, it seems that serum M30-M65 levels can presumably be an ancillary laboratory test to β-hCG in the diagnosis and follow-up of the patients with CHM.
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Wien. Klin. Wochenschr. · Dec 2016
Audit of geriatric hip fracture care - a Slovenian trauma center analysis.
The aim was to describe an audit of hip fracture patient care and outcomes in a Slovenian healthcare setting prior to the implementation of the Geriatric Fracture Center (GFC) model of care. ⋯ This comprehensive and detailed audit report provides baseline data on case-mix, care and outcomes following hip fractures in Slovenia, in advance of planned quality improvement work in geriatric fracture care and provides a strong basis for the assessment of the impact of the GFC model of care.
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Wien. Klin. Wochenschr. · Dec 2016
Pulse contour cardiac output monitoring in acute heart failure patients : Assessment of hemodynamic measurements.
Heart failure is known to be a major public health problem. Fluid redistribution contributes to acute heart failure; therefore, knowledge of hemodynamic parameters could be important for optimizing outcomes. The pulse contour cardiac output monitor PiCCO uses the single thermal indicator technique and pulse contour analysis to calculate hemodynamic parameters of preload, afterload, cardiac output, systemic vascular resistance and extravascular lung water. ⋯ We provide real world values for PiCCO parameters in acutely decompensated heart failure. In our study patients who were clinically in poorer health were monitored with PiCCO, resulting in increased mortality in this group. Further prospective studies to investigate the effects of treatment decisions triggered by information obtained by PiCCO monitoring for patients in acute heart failure are needed.
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Wien. Klin. Wochenschr. · Nov 2016
The evaluation in terms of sarcopenia of patients with fibromyalgia syndrome.
Fibromyalgia syndrome (FMS) is an extra-articular rheumatic illness, characterized by widespread body pain and decreased muscle function. Generalized loss of muscle mass and strength is named as sarcopenia. The objective of this study was to evaluate patients with FMS regarding sarcopenia. ⋯ Evaluation of female patients with primary FMS by the sarcopenia parameters could contribute a more objective evaluation during the patients' follow-up.