HIPEC after surgical cytoreduction in patients with rEOC appears beneficial compared to systemic chemotherapy treatment alone. The benefit is even greater in BRCA mutation carriers.
Aims
Heart failure (HF) is associated with considerable symptom burden and impairment in physical functioning and quality of life. The sodium–glucose co‐transporter 2 inhibitor empagliflozin reduced the risk of HF hospitalisation and cardiovascular death in patients with type 2 diabetes and established cardiovascular disease in the EMPA‐REG OUTCOME trial, and could potentially improve congestion symptoms and exercise capacity in patients with HF. We describe the designs of the EMPERIAL‐Preserved and EMPERIAL‐Reduced trials of empagliflozin in patients with chronic stable HF, with or without type 2 diabetes.
Methods
EMPERIAL‐Preserved and EMPERIAL‐Reduced are randomised, placebo‐controlled trials designed to investigate the effects of empagliflozin on exercise capacity and patient‐reported outcomes in patients with chronic stable HF with preserved ejection fraction [HFpEF; left ventricular ejection fraction (LVEF) > 40%] and HF with reduced ejection fraction (HFrEF; LVEF ≤ 40%), respectively. In each trial, approximately 300 patients will be randomised 1:1 to receive empagliflozin 10 mg or placebo once daily for 12 weeks. In both trials, the primary endpoint is the change from baseline in 6‐min walk test distance at week 12. Key secondary endpoints are the change from baseline in Kansas City Cardiomyopathy Questionnaire total symptom score and change from baseline in dyspnoea score of the Chronic Heart Failure Questionnaire at week 12.
Conclusion
The EMPERIAL‐Preserved and EMPERIAL‐Reduced trials will determine the effects of empagliflozin on exercise capacity and patient‐reported outcomes in patients with HFpEF and HFrEF, respectively, and provide insight into the potential of empagliflozin in the treatment of patients with HF.
Clinical Trial Registration: http://ClinicalTrials.gov ID: NCT03448406 (EMPERIAL‐Preserved), NCT03448419 (EMPERIAL‐Reduced).
Chronic heart failure (HF) is a growing epidemic, and therapy options are becoming more complex. Specifically, device management of HF represents a new "class" of therapy that can reduce mortality and alleviate morbidity of the disease syndrome. Heart failure training programs seldom provide structured opportunities for trainees to gain competence in device implantation and management. This curriculum outlines a new approach to training interventional HF cardiologists and internal medicine HF specialists to meet the growing demands for specially trained health care providers.
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