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EMPERIAL-reduced: A phase III randomized, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with reduced Ejection Fraction (HFrEF)

Study category: Heart and Blood Conditions

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Description

Participants will be randomly assigned to empagliflozin or placebo. Participants will take the study medication (empagliflozin or placebo) for 12 weeks.

Details
Age

Adult

Eligibility

- Patients with chronic HF diagnosed for at least 3 months before Visit 1 and currently in NYHA class II-IV - Chronic HF with reduced EF defined as LVEF ≤ 40 % as per echocardiography at Visit 1  - Elevated NT-proBNP > 450 pg/ml for patients without atrial fibrillation (AF) OR > 600 pg/ml for patients with AF - Patients must be clinically stable and on appropriate and stable dose of medical therapy for HF - Clinically stable at randomization with no signs of heart failure decompensation

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Neda Rasouli,  MD

Neda Rasouli, MD

Study ID

Protocol Number: 18-0926

ClinicalTrials.gov: NCT03448419

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