Lead Investigator: Changsheng Ma
Title of Proposal Research: The impact of malnutrition on the Efficacy and Safety of empagliflozin for heart failure With reduced ejection fraction
Vivli Data Request: 8850
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Heart failure is a syndrome of impaired cardiac circulation due to impaired systolic (when the heart contracts to pump blood around the body) and/or diastolic (when the heart relaxes and refills with blood) function of the heart and is the end stage of heart disease, with an estimated prevalence of >37.7 million individuals globally. Malnutrition is common in heart failure (HF), affecting up to 62% of patients with heart failure, and is associated with mortality.
Treatment with empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces the risk of adverse events in patients with heart failure. Empagliflozin works by reducing the amount of glucose being reabsorbed into the blood from the kidneys so that the glucose is passed out in the urine, and hence blood glucose levels are lowered. SGLT2 inhibitors have been seen to cause weight loss in heart failure patients as sugar is a very important nutrient. However, whether empagliflozin benefits patients with malnutrition in the same way it does in other patients is unclear. This analysis of individual participant data (IPD) from two clinical trials of patients with chronic heart failure may provide guidance on whether empagliflozin is recommended in clinical practice in patients with malnutrition and heart failure.
This subanalysis from EMPEROR-Reduced trial may provide guidance on whether empagliflozin is recommended in clinical practice in patients with malnutrition and heart failure with reduced ejection fraction (HFrEF – when one of the chambers on the left side of the heart loses its ability to contract normally. The heart can’t pump with enough force to push enough blood into circulation).
Requested Studies:
A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Data Contributor: Boehringer Ingelheim
Study ID: NCT03057977
Sponsor ID: 1245.121