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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: Completed Phase 3 study of Heart Failure, sponsored by Boehringer Ingelheim.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical benefit, a composite of death, number of HFEs, time to first HFE and change from baseline (CfB) in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) after 90 days of treatment. All patients randomised to empagliflozin are compared to all patients randomised to placebo within strata. For any two patients, a patient will win, i.e. achieve a better clinical outcome, as determined by assessing the following criteria sequentially, stopping when an advantage for either p
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
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2020-05-18 |
| Est. Completion | 2021-06-02 |
| Phase | Phase 3 |
What the finished NCT04157751 record still lists
NCT04157751 is an interventional study that assigns participants to a tested intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (74% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04157751's enrollment target sits among peer trials
530 96th of 397 higher than 302 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
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