Lead Investigator: João Pedro Ferreira, Faculty of Medicine of Porto University
Title of Proposal Research: Anemia and the Effect of Empagliflozin in Heart Failure with Preserved Ejection Fraction (HFpEF) findings from EMPEROR-Preserved
Vivli Data Request: 9383
Funding Source: None
Potential Conflicts of Interest: I was a member of the Steering Committee for the EMPEROR studies, but I do not have any patents nor receive any payment from Boehringer-Ingelheim.
I will acknowledge/declare any potential conflicts of interest in any subsequent publication.
Summary of the Proposed Research:
Anemia is a condition that occurs when a person’s blood does not have enough healthy red blood cells (the hematocrit level) or hemoglobin to carry oxygen to the body’s tissues. Hemoglobin is a protein found in red cells that carries oxygen from the lungs to all other organs in the body. Anemia is a frequent co-morbid condition among patients with heart failure with preserved ejection fraction (HFpEF), affecting around 40% of the patients with HFpEF i.e., patients in whom the heart has problems in relaxation and filling with blood, a condition affecting more than 10% of elderly people (>75 years). Anemia may have multiple etiologies (i.e. causes), however in patients with HFpEF, anemia is usually hypoproliferative (where the bone marrow is not able to produce adequate numbers of red blood cells), caused by deficient iron utilization or low iron stores, vitamin deficiency, chronic inflammation, kidney disease, or conditions affecting the bone marrow.
Regardless of the underlying etiology, anemia is associated with low exercise capacity, impaired quality of life and a poor prognosis including a higher risk of heart failure (HF) hospitalizations and mortality.
Sodium glucose co-transporter 2 (SGLT2) inhibitors are medicines which increase hemoglobin/hematocrit and, therefore, have the potential to correct anemia.
The effect of SGLT2 inhibitors (SGLTi) on correcting anemia among patients with HFpEF has not been studied yet.
This study aims to compare the characteristics of the patients with and without anemia at baseline, study the impact of the SGLT2 inhibitor empagliflozin on hematocrit/hemoglobin and the onset of new anemia throughout the follow-up, and to assess whether the effect of empagliflozin on a broad range of outcomes was consistent irrespective of the anemia status at
baseline in patients with HFpEF enrolled in the EMPEROR-Preserved (NCT03057951) trial.
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 Preserved Ejection Fraction (HFpEF)
Data Contributor: Boehringer Ingelheim
Study ID: NCT03057951
Sponsor ID: 1245.110