Effect of Empagliflozin on Blood Volume Redistribution in Patients With Chronic Heart Failure and Reduced Ejection Fraction: An Analysis From the Empire HF Randomized Clinical Trial
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Background: Stressed blood volume (SBV) is a major determinant of systemic and pulmonary venous pressures which, in turn, determine left and right ventricular fillings and regulates cardiac output via the Frank-Starling mechanism. It is not known whether inhibition of the SGLT2 (sodium-glucose cotransporter-2) favorably affects SBV. We investigated the effect of empagliflozin on estimated SBV in patients with heart failure and reduced ejection fraction compared with placebo. Methods: This was a post hoc analysis of an investigator-initiated, double-blinded, placebo-controlled, randomized trial. Seventy patients were assigned to empagliflozin 10 mg or matching placebo once daily for 12 weeks. Patients underwent right heart catheterization at rest and during exercise at baseline and follow-up. The outcome was change in estimated SBV after 12 weeks of empagliflozin treatment over the full range of exercise, determined using a recently introduced analytical approach based on invasive hemodynamic assessment. Results: Patients with heart failure and reduced ejection fraction, mean age, 57 years and mean ejection fraction 27%, with 47 patients (71%) receiving diuretics were randomized. The effect of empagliflozin on estimated SBV over the full range of exercise loads showed a statistically significant reduction compared with placebo (-198.4 mL [95% CI, -317.4 to -79.3] P=0.001), a 9% decrease. The decrease in estimated SBV by empagliflozin was significantly correlated with the decrease in PCWP (R=-0.33, P<0.0001). The effect of empagliflozin was consistent across subgroup analysis. Conclusions: Empagliflozin treatment significantly reduced SBV compared with placebo after 12 weeks of treatment in patients with stable chronic heart failure and reduced ejection fraction during sub maximal exercise. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03198585.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Circulation: Heart Failure |
| Vol/bind | 15 |
| Udgave nummer | 3 |
| Sider (fra-til) | E009156 |
| ISSN | 1941-3289 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
Dr Omar reports grants from the Danish Heart Foundation, The Steno Diabetes Center Odense, and the A.P. Møller Foundation during the conduct of the study. Dr Jensen reports grants from the Research Council at Herlev and Gentofte University Hospital, the Research and Innovation Foundation of the Department of Cardiology (FUHAS; formerly FUKAP), Herlev and Gentofte University Hospital, and the A.P. Møller Foundation for the Advancement of Medical Science, during the conduction of the study; grants from the Danish Heart Foundation and the Research and Innovation Foundation of the Department of Cardiology (FUHAS; formerly FUKAP), Herlev and Gentofte University Hospital and personal fees from scientific advisory board from AstraZeneca, outside the submitted work. Dr Burkhoff reports consulting to PVLoops LLC and Axon Therapeutics. Dr Kistorp reports personal fees from scientific advisory panels and speaker fees from Boehringer Ingelheim, Merck, Sharp & Dohme, AstraZeneca, Amgen, Novartis, Novo Nordisk and Shire, outside the submitted work. Dr Gustafsson reports personal fees from Boehringer Ingelheim, during the conduct of the study, personal fees from Novartis, grants and personal fees from Pfizer, and personal fees from Orion Pharma Abbott, Bayer, AstraZeneca, and Carmat, outside the submitted work. Dr Køber reports personal fees from speaker honoraria from Novartis, AstraZeneca, and Boehringer Ingelheim, outside the submitted work. Dr Borlaug reports grants from research project grant program (RO1) HL128526R01 from the National Institutes of Health. Dr Schou reports a grant from The Capital Region of Denmark and grants from the Danish Heart Foundation, during the conduct of the study; personal fees and nonfinancial support from AstraZeneca, and personal fees from Novo Nordisk and Boehringer Ingelheim, outside the submitted work. Dr Møller reports grant and personal fees from Abiomed and personal fees from Novartis, Abbott, Boehringer Ingelheim, and Orion Pharma, outside the submitted work. The other authors report no conflicts.
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