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AzTrials

Heart FailurePhase 3NCT04157751

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

A Phase 3 study testing Empagliflozin in people with Heart Failure, run by Boehringer Ingelheim at 118 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Empagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
530 participants
Where
118 sitesin 15 countries
Study dates
18 May 2020to 2 Jun 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently hospitalised for the primary diagnosis of acute heart failure (de novo or decompensated chronic HF), regardless of ejection fraction (EF). Patients with a diagnosis of hospitalized heart failure must have HF symptoms at the time of hospital admission
  • Evidence of left ventricular ejection fraction (LVEF, either reduced or preserved EF) as per local reading preferably measured during current hospitalisation or in the 12 months prior to randomisation
  • Patients must be randomised after at least 24 hours and no later than 5 days after admission, as early as possible after stabilization and while still in hospital
  • Patients must fulfil the following stabilisation criteria (while in the hospital):
  • SBP ≥100mm Hg and no symptoms of hypotension in the preceding 6 hours,
  • no increase in i.v. diuretic dose for 6 hours prior to randomisation,
Show all 11Show fewer
  • no i.v. vasodilators including nitrates within the last 6 hours prior to randomisation
  • no i.v. inotropic drugs for 24 hours prior to randomisation.
  • Elevated NT-proBNP ≥ 1600pg/mL or BNP ≥400 pg/mL according to the local lab, for patients without atrial fibrillation (AF); or elevated NT-proBNP ≥ 2400pg/mL or BNP ≥600 pg/mL for patients with AF, measured during the current hospitalization or in the 72 hours prior to hospital admission,. For patients treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation, only NT-proBNP values should be used
  • HF episode leading to hospitalisation must have been treated with a minimum single dose of 40 mg of i.v. furosemide (or equivalent i.v. loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide)
  • Further Inclusion Criteria Apply

Who cannot join

  • Cardiogenic shock
  • Current hospitalisation for acute heart failure primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infarction (AMI)
  • Current hospitalisation for acute heart failure not caused primarily by intravascular volume overload;
  • Below interventions in the past 30 days prior to randomisation or planned during the study:
  • Major cardiac surgery, or TAVI (Transcatheter Aortic Valve Implantation), or PCI, or Mitraclip
  • All other surgeries that are considered major according to investigator judgement
Show all 16Show fewer
  • Implantation of cardiac resynchronisation therapy (CRT) device
  • cardiac mechanical support implantation
  • Carotid artery disease revascularisation (stent or surgery)
  • Acute coronary syndrome / myocardial infarction, stroke or transient ischemic attack (TIA) in the past 90 days prior to randomisation
  • Heart transplant recipient, or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement), or planned for palliative care for HF, or currently using left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) or any other type of mechanical circulatory support, or patients on mechanical ventilation, or patients with planned inotropic support in an outpatient setting
  • Haemodynamically significant (severe) uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)
  • Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 as measured during hospitalization (latest local lab measurement before randomisation) or requiring dialysis
  • Type 1 Diabetes Mellitus (T1DM)
  • History of ketoacidosis, including diabetic ketoacidosis (DKA)
  • Further Exclusion Criteria Apply

Trial locations and contacts

118 sites in 15 countries.

118 sites in 15 countries

United States30 sites

  • Pharmatex Research

    Amarillo, Texas, 79109

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Erie County Medical Center

    Buffalo, New York, 14215

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Ralph H. Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Cardiology Associates Research Co.

    Daytona Beach, Florida, 32117

  • Cardiovascular Associates of the Delaware Valley

    Elmer, New Jersey, 08318

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • The DeMatteis Center for Cardiac Research and Education

    Greenvale, New York, 11548

  • University Of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • South Oklahoma Heart Research Group

    Oklahoma City, Oklahoma, 73135

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of California Irvine

    Orange, California, 92865

  • Methodist Medical Center

    Peoria, Illinois, 61603

  • Center for Advanced Cardiac Care - Heart Failure Clinic

    Plano, Texas, 75093

  • North Carolina Heart and Vascular

    Raleigh, North Carolina, 27607

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Stony Brook Medicine

    Stony Brook, New York, 11794

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Jefferson Washington Township Hospital

    Washington Township, New Jersey, 08080

Other trials in United States

Germany11 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203

  • Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser

    Bremen, 28277

  • Herzzentrum Dresden GmbH Universitätsklinik

    Dresden, 01307

  • Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35392

  • Universitätsklinikum Jena

    Jena, 07743

  • Asklepios Klinik Langen-Seligenstadt GmbH

    Langen, 63225

  • Klinikum Leverkusen gGmbH, Leverkusen

    Leverkusen, 51375

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

  • Universitätsklinikum Würzburg AÖR

    Würzburg, 97080

Other trials in Germany

Italy10 sites

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123

  • Università degli Studi "Magna Grecia" - Campus "S. Venuta"

    Catanzaro, 88100

  • Ospedale della Val di Chiana Santa Margherita

    Cortona, 52040

  • Az.Osp. Universitaria "Ospedali Riuniti"

    Foggia, 71100

  • Centro Cardiologico Monzino-IRCCS

    Milan, 20138

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Osp. Guglielmo da Saliceto AUSL di Piacenza

    Piacenza, 29121

  • IRCCS San Raffaele

    Roma, 00163

  • AO Città della Salute e della

    Torino, 10126

  • Azienda Sanitaria Universitaria Giuliano Isontina

    Trieste, 34124

Other trials in Italy

Netherlands10 sites

  • Jeroen Bosch Ziekenhuis-Hertogenbosch

    's-Hertogenbosch, 5223 GZ

  • Gelre Ziekenhuizen Apeldoorn

    Apeldoorn, 7334 DZ

  • TREANT Zorggroep

    Emmen, 7824 AA

  • Groene Hart ziekenhuis

    Gouda, 2803 HH

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Sint Jansdal Ziekenhuis

    Harderwijk, 3844 DG

  • Alrijne Leiderdorp

    Leiderdorp, 2353 GA

  • Bravis ziekenhuis, locatie Roosendaal

    Roosendaal, 4708 AE

  • HagaZiekenhuis

    The Hague, 2545 AA

  • Diakonessenhuis Utrecht

    Utrecht, 3582 KE

Other trials in Netherlands

Japan9 sites

  • Japan Community Health Care Organization Kyushu Hospital

    Fukuoka, Kitakyushu, 806-8501

  • Mito Medical Center

    Ibaraki, Higashiibaraki-gun, 311-3193

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051

  • Shinshu University Hospital

    Nagano, Matsumoto, 390-8621

  • The Sakakibara Heart Institute of Okayama

    Okayama, Okayama, 700-0804

  • Osaka University Hospital

    Osaka, Suita, 565-0871

  • Kawaguchi Cardiovascular and Respiratory Hospital

    Saitama, Kawaguchi, 333-0842

  • Saitama Sekishikai Hospital

    Saitama, Sayama, 350-1305

  • Nihon University Itabashi Hospital

    Tokyo, Itabashi-ku, 173-8610

Other trials in Japan

Belgium7 sites

  • Aalst - HOSP Onze-Lieve-Vrouw

    Aalst, 9300

  • Brussels - UNIV UZ Brussel

    Brussels, 1090

  • AZ Sint-Blasius

    Dendermonde, 9200

  • Ziekenhuis Oost-Limburg - Campus Sint-Jan

    Genk, 3600

  • UZ Leuven

    Leuven, 3000

  • Liège - HOSP CHR de la Citadelle

    Liège, 4000

  • UNIV Ambroise Paré

    Mons, 7000

Other trials in Belgium

Spain7 sites

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital Puerta de Hierro

    Majadahonda, 28222

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Moises Broggi

    Sant Joan Despí, 08970

  • Hospital Nuestra Señora de Valme

    Seville, 41014

  • Hospital Clínico de Valencia

    Valencia, 46010

Other trials in Spain

China6 sites

  • Beijing Chao-Yang Hospital

    Beijing, 100020

  • Beijing AnZhen Hospital

    Beijing, 100029

  • The First Hospital of Jilin University

    Changchun, 130021

  • West China Hospital

    Chengdu, 610041

  • First Affiliated Hospital of Xi'an JiaoTong University

    Xi'an, 710061

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen, 361004

Other trials in China

Denmark5 sites

  • Aalborg Universitetsshospital

    Aalborg, 9000

  • Frederiksberg Hospital

    Frederiksberg, 2000

  • Herlev and Gentofte Hospital

    Herlev, 2733

  • Hvidovre Hospital

    Hvidovre, 2650

  • Viborg Regionhospital

    Viborg, 8800

Other trials in Denmark

Hungary5 sites

  • Semmelweis University

    Budapest, 1088

  • University Debrecen Hospital

    Debrecen, 4032

  • University of Pecs

    Pécs, 7624

  • Fejer County Saint George University Teaching Hospital

    Székesfehérvár, 8000

  • Csongrad Country Dr Bugyi Istvan Hosp.

    Szentes, 6600

Other trials in Hungary

Norway5 sites

  • Helse Førde HF, Førde Sentralsjukehus

    Førde, N-6812

  • Sykehuset Innlandet HF, Avd. Lillehammer

    Lillehammer, N-2609

  • Akershus Universitetssykehus HF

    Lørenskog, N-1478

  • Helse Stavanger, Stavanger Universitetssykehus

    Stavanger, N-4011

  • Universitetssykehuset Nord-Norge, Tromsø

    Tromsø, N-9019

Other trials in Norway

Czechia4 sites

  • University Hospital Brno

    Brno, 639 00

  • Univ.Hosp U Svate Anny, I.Internal Clinic-Cardiology,Brno

    Brno, 65691

  • University Hospital Motol

    Prague, 15006

  • District Hospital, Tabor

    Tábor, 390 03

Other trials in Czechia

Poland4 sites

  • Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia

    Gdynia, 81348

  • Card.Cli.Mil.Med.Ac.Uni.Cli.Hosp. Cent.Vetera.Hosp.Lodz

    Lodz, 90549

  • Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard

    Lodz, 92-213

  • Provincial Specialist M. Kopernik Hospital

    Lodz, 93-513

Other trials in Poland

Canada3 sites

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Royal Jubilee Hospital

    Victoria, British Columbia, V8R 1J8

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Sweden2 sites

  • Sahlgrenska US, Göteborg

    Gothenburg, 41345

  • Sahlgrenska Universitetssjukhuset, Östra

    Gothenburg, 416 85

Other trials in Sweden

About this study

Official title: 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)

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

Read more

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
Being tested
Empagliflozin, Placebo to Empagliflozin
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmpagliflozinDrug

    Film-coated tablet

  • Placebo to EmpagliflozinDrug

    Film-coated tablet

Study groups in NCT04157751
Study groupRoleWhat they receive
EmpagliflozinExperimentalNot described
Receives: Drug: Empagliflozin
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo to Empagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Pairwise Comparisons With Wins of Clinical Benefit, a Composite of Death, Number of Heart Failure Events (HFEs), Time to the First HFE and ≥5-point Difference in CfB in KCCQ-TSS After 90 Days of Treatment

    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 patient is shown:

    1. Death: death is worse than no death; earlier death is worse; tied if not possible to determine.
    2. Number of HFEs: more HFEs is worse; tied, if same number of HFEs.
    3. Time to first HFE: earlier HFE is worse; tied, if not possible to determine.
    4. KCCQ-TSS CfB at Day 90: more positive CfB is better; the threshold for the difference is >= 5 for a win; tied, if difference < 5.

    The KCCQ-TSS ranges from 0 to 100, where a higher score reflects a better outcome.

    pct. = percentage

    Measured: Up to 90 days. For KCCQ-TSS: at baseline and at day 90.

Secondary outcomes (10)

  1. Number of Participants With Improvement of at Least 10 Points in KCCQ-TSS After 90 Days of Treatment

    Number of participants with improvement of at least 10 points in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) from baseline after 90 days of treatment.

    The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into the total symptom score. Scores are represented on a 0-to-100-point scale, where a higher score reflects a better health status.

    Measured: At baseline and at day 90.

  2. Change From Baseline in KCCQ-TSS After 90 Days of Treatment

    Change from baseline in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS).

    The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into the total symptom score. The score is represented on a 0-to-100-point scale, where a higher score reflects a better health status.

    Change from baseline in KCCQ-TSS at day 90 was modeled using a MMRM with visit (day 15 and day 30) as repeated measures, adjusted mean (standard error) after 90 days of treatment is reported.

    Measured: At baseline, at day 15, 30 and at day 90.

  3. Change From Baseline in Log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) Area Under the Curve (AUC) Over 30 Days of Treatment

    Change from baseline in log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) Area under the curve (AUC) over 30 days of treatment is reported.

    Measured: From baseline to day 30.

  4. Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 30 Days After Initial Hospital Discharge

    The follow-up time for DAOH analyses was defined as 30 days after initial hospital discharge, or time between initial hospital discharge and date of censoring for non-fatal events except for patients who died within the first 30 days, where 30 days was considered as the DAOH follow-up time.

    DAOH for each patient was calculated as follow-up time subtracted by the number of days in hospital during the 30 days after initial hospital discharge as well as the number of days being dead within the 30 days. Percentage DAOH was defined as DAOH divided by the DAOH follow-up time of each patient multiplied by 100.

    Measured: Up to 30 days after initial hospital discharge.

  5. Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 90 Days After Randomisation

    The follow-up time for DAOH analyses was defined as 90 days after randomisation, or time between randomisation and date of censoring for non-fatal events except for patients who died within the first 90 days, where 90 days was considered as the DAOH follow-up time. DAOH for each patient was calculated as follow-up time subtracted by the number of days in hospital during the 90 days after randomisation as well as the number of days being dead within the first 90 days.

    Percentage DAOH was defined as DAOH divided by the DAOH follow-up time of each patient multiplied by 100.

    Measured: Up to 90 days after randomisation.

  6. Incidence Rate of First Occurrence of Cardiovascular (CV) Death or Heart Failure Event (HFE) Until End of Trial Visit

    Incidence rate of first occurrence of CV death or HFE until end of trial visit per 100 patient-year (pt-yrs) at risk is reported.

    Incidence rate per 100 pt-yrs = 100* number of patients with event / time at risk [years].

    Measured: Up to 127 days.

  7. Number of Participants With Hospitalization for Heart Failure (HHF) Until 30 Days After Initial Hospital Discharge

    Number of participants with hospitalization for heart failure (HHF) until 30 days after initial hospital discharge.

    Measured: Up to 30 days after initial hospital discharge.

  8. Composite Renal Endpoint: Number of Participants With Chronic Dialysis, Renal Transplant, Sustained Reduction in eGFR(CKD-EPI)cr

    The occurrence of the composite renal endpoint:

    • chronic dialysis (with a frequency of twice per week or more for at least 90 days), or
    • renal transplant, or
    • sustained reduction in Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) from baseline of ≥40%, or
    • sustained eGFR [mL/min/1.73 m2] <15 and baseline value ≥30, or
    • sustained eGFR <10 and baseline value <30; is reported by number of participants with component events. (These events may have occurred after the endpoint was already met. Combinations may not have occurred on the same day).

    Sustained was determined by 2 or more consecutive post-baseline central laboratory measurements separated by at least 30 days.

    Measured: Up to 90 days.

  9. Weight Change Per Mean Daily Loop Diuretic Dose After 15 Days of Treatment

    Diuretic effect as assessed by weight change per mean daily loop diuretic dose after 15 days of treatment.

    Diuretic dose = 40 mg intravenous furosemide or 80 mg oral furosemide.

    Abbreviation:

    Kg: Kilogram

    Measured: At baseline and at day 15.

  10. Weight Change Per Mean Daily Loop Diuretic Dose After 30 Days of Treatment

    Diuretic effect as assessed by weight change per mean daily loop diuretic dose after 30 days of treatment.

    Diuretic dose = 40 mg intravenous furosemide or 80 mg oral furosemide

    Abbreviation:

    Kg: Kilogram

    Measured: At baseline and at day 30.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2019
  2. Study start18 May 2020
  3. Primary completion28 May 2021
  4. Study completion2 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
530 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04157751
Sponsor's protocol ID
1245-0204
Other IDs
2019-002946-19, 2019
Status last verified
Jun 2022
First submitted
4 Nov 2019
Last updated
19 Jul 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Publications

  • Angermann CE, Gerhardt T, Blatchford JP, Biegus J, Collins SP, Kosiborod M, Ferreira JP, Nassif ME, Psotka MA, Tromp J, Kraus BJ, Ponikowski P, Teerlink JR, Voors AA. Empagliflozin in De Novo vs Acute Decompensated Chronic Heart Failure: A Prespecified Analysis From EMPULSE. JACC Heart Fail. 2026 Aug;14(8):102999. doi: 10.1016/j.jchf.2026.102999. Epub 2026 Mar 7.

    PubMed 41793401

  • Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Dec 1;36(12):2421-2430. doi: 10.1681/ASN.0000000766. Epub 2025 Jun 17.

    PubMed 40526444

  • Ferreira JP, Blatchford JP, Teerlink JR, Kosiborod MN, Angermann CE, Biegus J, Collins SP, Tromp J, Nassif ME, Psotka MA, Comin-Colet J, Mentz RJ, Brueckmann M, Nordaby M, Ponikowski P, Voors AA. Mineralocorticoid receptor antagonist use and the effects of empagliflozin on clinical outcomes in patients admitted for acute heart failure: Findings from EMPULSE. Eur J Heart Fail. 2023 Oct;25(10):1797-1805. doi: 10.1002/ejhf.2982. Epub 2023 Aug 22.

    PubMed 37540060

  • Kosiborod MN, Angermann CE, Collins SP, Teerlink JR, Ponikowski P, Biegus J, Comin-Colet J, Ferreira JP, Mentz RJ, Nassif ME, Psotka MA, Tromp J, Brueckmann M, Blatchford JP, Salsali A, Voors AA. Effects of Empagliflozin on Symptoms, Physical Limitations, and Quality of Life in Patients Hospitalized for Acute Heart Failure: Results From the EMPULSE Trial. Circulation. 2022 Jul 26;146(4):279-288. doi: 10.1161/CIRCULATIONAHA.122.059725. Epub 2022 Apr 4.

    PubMed 35377706

  • Voors AA, Angermann CE, Teerlink JR, Collins SP, Kosiborod M, Biegus J, Ferreira JP, Nassif ME, Psotka MA, Tromp J, Borleffs CJW, Ma C, Comin-Colet J, Fu M, Janssens SP, Kiss RG, Mentz RJ, Sakata Y, Schirmer H, Schou M, Schulze PC, Spinarova L, Volterrani M, Wranicz JK, Zeymer U, Zieroth S, Brueckmann M, Blatchford JP, Salsali A, Ponikowski P. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat Med. 2022 Mar;28(3):568-574. doi: 10.1038/s41591-021-01659-1. Epub 2022 Feb 28.

    PubMed 35228754

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin in people with Heart Failure, run by Boehringer Ingelheim at 118 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Germany, Italy, Netherlands, Japan and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Pairwise Comparisons With Wins of Clinical Benefit, a Composite of Death, Number of Heart Failure Events (HFEs), Time to the First HFE and ≥5-point Difference in CfB in KCCQ-TSS After 90 Days of Treatment (time frame: Up to 90 days. For KCCQ-TSS: at baseline and at day 90.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04157751, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.

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