NCT04157751

A Study to Test the Effect of Empagliflozin in Patients Who Are in Hospital for Acute Heart Failure

A Multicentre, Randomised, Double-blind, 90-day Superiority Trial to Evaluate the Effect on Clinical Benefit, Safety and Tolerability of Once Daily Oral EMPagliflozin 10 mg Compared to Placebo, Initiated in Patients Hospitalised for acUte Heart faiLure (de Novo or Decompensated Chronic HF) Who Have Been StabilisEd (EMPULSE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study in adults who are in hospital for acute heart failure. The purpose of this study is to find out whether starting to take a medicine called empagliflozin soon after first being treated in hospital helps people with acute heart failure. Participants are in the study for about 3 months. At the beginning, participants are still in hospital. Later, they visit the hospital about 3 times and get 1 phone call. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. It is used to treat type 2 diabetes. During the study, the doctors check whether participants have additional heart failure events like needing to go to the hospital again because of heart failure. The participants answer questions about how their heart failure affects their life. We then compare the results between the empagliflozin and placebo groups. The doctors also regularly check the general health of the participants.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Empagliflozin	Film-coated tablet
DRUG	Placebo to Empagliflozin	Film-coated tablet

Timeline

• Start date: 2020-05-18
• Primary completion: 2021-05-28
• Completion: 2021-06-02
• First posted: 2019-11-08
• Last updated: 2022-07-19
• Results posted: 2022-06-06

Locations

118 sites across 15 countries: United States, Belgium, Canada, China, Czechia, Denmark, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Spain, Sweden

Regulatory

• FDA-regulated drug study