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NCT04157751 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Heart Failure, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
530
Enrollment target
20
Study locations

NCT04157751 is a Phase 3 study of Heart Failure that has completed, run by Boehringer Ingelheim. The registered enrollment target is 530 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT04157751, a Phase 3 study of Heart Failure, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
530 participants
Enrollment target
20
Study locations

Study 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 Studied

Interventions

  • DRUG Empagliflozin
  • DRUG Placebo to Empagliflozin

Study Locations (20)

California

  • University of Southern California - Los Angeles
  • Cedars-Sinai Medical Center - Los Angeles
  • University of California Irvine - Orange
  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance

New York

  • Erie County Medical Center - Buffalo
  • The DeMatteis Center for Cardiac Research and Education - Greenvale
  • Stony Brook Medicine - Stony Brook
  • Montefiore Medical Center - The Bronx

Florida

  • Cardiology Associates Research Co. - Daytona Beach
  • University of Florida Health Jacksonville - Jacksonville

New Jersey

  • Cardiovascular Associates of the Delaware Valley - Elmer
  • Jefferson Washington Township Hospital - Washington Township

Georgia

  • Grady Memorial Hospital - Atlanta

Illinois

  • Methodist Medical Center - Peoria

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston

Minnesota

  • United Hospital - Saint Paul

Trial Details

FieldValue
Enrollment Target 530 participants
Start Date 2020-05-18
Est. Completion 2021-06-02
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT04157751

The ClinicalTrials.gov registry entry for NCT04157751 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 530 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (74% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Empagliflozin is the first listed.

NCT04157751 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, New York, Florida.

Frequently Asked Questions

What is clinical trial NCT04157751 about?

NCT04157751 is a clinical study titled "A Study to Test the Effect of Empagliflozin in Patients Who Are in Hospital for Acute Heart Failure". 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...

What is the current status of trial NCT04157751?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2020-05-18. Estimated completion is 2021-06-02.

What conditions does trial NCT04157751 study?

This clinical trial studies the following conditions: Heart Failure.

What interventions are being tested in trial NCT04157751?

The interventions under investigation include: Empagliflozin (DRUG), Placebo to Empagliflozin (DRUG).

Who is sponsoring clinical trial NCT04157751?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04157751 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.