Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF
العنوان: | Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF |
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المؤلفون: | Farhan Raza, Jeremy A. Mazurek, Jonathan D. Rich, Daniel Burkhoff, Ronald Zolty, Barry A. Borlaug, Sanjiv J. Shah, Ioana R. Preston, Gregory D. Lewis, Eugene S. Chung, David T. Majure, Stuart Rich, Marc A. Simon, Ryan J. Tedford, Thenappan Thenappan, Roham T. Zamanian |
المصدر: | JACC: Heart Failure. 9:360-370 |
بيانات النشر: | Elsevier BV, 2021. |
سنة النشر: | 2021 |
مصطلحات موضوعية: | medicine.medical_specialty, Supine position, business.industry, Hemodynamics, Levosimendan, 030204 cardiovascular system & hematology, medicine.disease, Placebo, Pulmonary hypertension, 03 medical and health sciences, 0302 clinical medicine, Heart failure, Internal medicine, Cardiology, medicine, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, Heart failure with preserved ejection fraction, Pulmonary wedge pressure, business, medicine.drug |
الوصف: | Objectives The purpose of this study was to evaluate the effects of intravenous levosimendan on hemodynamics and 6-min walk distance (6MWD) in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Background There are no proven effective treatments for patients with PH-HFpEF. Methods Patients with mean pulmonary artery pressure (mPAP) ≥35 mm Hg, pulmonary capillary wedge pressure (PCWP) ≥20 mm Hg, and LVEF ≥40% underwent 6MWD and hemodynamic measurements at rest, during passive leg raise, and supine cycle exercise at baseline and after an open-label 24-h levosimendan infusion (0.1 μg/kg/min). Hemodynamic responders (those with ≥4 mm Hg reduction of exercise-PCWP) were randomized (double blind) to weekly levosimendan infusion (0.075 to 0.1ug/kg/min for 24 h) or placebo for 5 additional weeks. The primary end point was exercise-PCWP, and key secondary end points included 6MWD and PCWP measured across all exercise stages. Results Thirty-seven of 44 patients (84%) met responder criteria and were randomized to levosimendan (n = 18) or placebo (n = 19). Participants were 69 ± 9 years of age, 61% female, and with resting mPAP 41.0 ± 9.3 mm Hg and exercise-PCWP 36.8 ± 11.3 mm Hg. Compared with placebo, levosimendan did not significantly reduce the primary end point of exercise-PCWP at 6 weeks (−1.4 mm Hg; 95% confidence interval [CI]: −7.8 to 4.8; p = 0.65). However, levosimendan reduced PCWP measured across all exercise stages (−3.9 ± 2.0 mm Hg; p = 0.047). Levosimendan treatment resulted in a 29.3 m (95% CI: 2.5 to 56.1; p = 0.033) improvement in 6MWD compared with placebo. Conclusions Six weeks of once-weekly levosimendan infusion did not affect exercise-PCWP but did reduce PCWP incorporating data from rest and exercise, in tandem with increased 6MWD. Further study of levosimendan is warranted as a therapeutic option for PH-HFpEF. (Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF [HELP]; NCT03541603 ) |
تدمد: | 2213-1779 |
URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::752ca49e879129e4607d4aae4c7d2a61 https://doi.org/10.1016/j.jchf.2021.01.015 |
حقوق: | OPEN |
رقم الأكسشن: | edsair.doi...........752ca49e879129e4607d4aae4c7d2a61 |
قاعدة البيانات: | OpenAIRE |
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