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EMPERIAL-preserved: 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 preserved Ejection Fraction (HFpEF)

Study category: Heart and Blood Conditions

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Description

Subjects enrolled in this trial will be randomly assigned to receive either Empagliflozin 10 mg or placebo for 12 weeks.

Details
Age

Adult

Eligibility

- Patients with CHF diagnosed for at least 3 months before Visit 1 and currently in NYHA class II-IV - CHF with preserved EF defined as left ventricular ejection fraction (LVEF) > 40% as per echocardiography at Visit 1 and no prior measurement of LVEF ≤ 40% - Elevated NT-proBNP > 300 pg/ml for patients without atrial fibrillation (AF), OR > 600 pg/ml for patients with AF - Patients must be on an appropriate and stable dose of oral diuretics for at least 2 weeks prior to Visit 1. - 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: 18-0925

ClinicalTrials.gov: NCT03448406

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