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COMPLETED Phase 3

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

NCT04157751 · View on ClinicalTrials.gov ↗

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

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04157751

The ClinicalTrials.gov registry entry for NCT04157751 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 530 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04157751 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, New York, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04157751?

The interventions under investigation include: Empagliflozin (DRUG), Placebo to Empagliflozin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04157751?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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