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

June 28, 2022 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
530

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Aalst - HOSP Onze-Lieve-Vrouw
      • Brussel, Belgium, 1090
        • Brussels - UNIV UZ Brussel
      • Dendermonde, Belgium, 9200
        • AZ Sint-Blasius
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg - Campus Sint-Jan
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • Liège - HOSP CHR de la Citadelle
      • Mons, Belgium, 7000
        • UNIV Ambroise Paré
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Royal Jubilee Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
  • China
      • Beijing, China, 100029
        • Beijing Anzhen Hospital
      • Beijing, China, 100020
        • Beijing Chao-Yang Hospital
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Chengdu, China, 610041
        • West China Hospital
      • Xiamen, China, 361004
        • Xiamen Cardiovascular Hospital Xiamen University
      • Xian, China, 710061
        • First Affiliated Hospital of Xi'an JiaoTong University
  • Czechia
      • Brno, Czechia, 65691
        • Univ.Hosp U Svate Anny, I.Internal Clinic-Cardiology,Brno
      • Brno, Czechia, 639 00
        • University Hospital Brno
      • Prag, Czechia, 15006
        • University Hospital Motol
      • Tabor, Czechia, 390 03
        • District Hospital, Tabor
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Universitetsshospital
      • Frederiksberg, Denmark, 2000
        • Frederiksberg Hospital
      • Herlev, Denmark, 2733
        • Herlev and Gentofte Hospital
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Viborg, Denmark, 8800
        • Viborg Regionhospital
  • Germany
      • Berlin, Germany, 12203
        • Charite - Universitätsmedizin Berlin
      • Bremen, Germany, 28277
        • Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser
      • Dresden, Germany, 01307
        • Herzzentrum Dresden GmbH Universitätsklinik
      • Freiburg, Germany, 79106
        • Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH
      • Gießen, Germany, 35392
        • Universitätsklinikum Gießen und Marburg GmbH
      • Jena, Germany, 07743
        • Universitätsklinikum Jena
      • Langen, Germany, 63225
        • Asklepios Klinik Langen-Seligenstadt GmbH
      • Leverkusen, Germany, 51375
        • Klinikum Leverkusen gGmbH, Leverkusen
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg AÖR
  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University
      • Debrecen, Hungary, 4032
        • University Debrecen Hospital
      • Pecs, Hungary, 7624
        • University of Pécs
      • Szekesfehervar, Hungary, 8000
        • Fejer County Saint George University Teaching Hospital
      • Szentes, Hungary, 6600
        • Csongrad Country Dr Bugyi Istvan Hosp.
  • Italy
      • Brescia, Italy, 25123
        • ASST degli Spedali Civili di Brescia
      • Catanzaro, Italy, 88100
        • Università degli Studi "Magna Grecia" - Campus "S. Venuta"
      • Cortona, Italy, 52040
        • Ospedale della Val di Chiana Santa Margherita
      • Foggia, Italy, 71100
        • Az.Osp. Universitaria "Ospedali Riuniti"
      • Milano, Italy, 20138
        • Centro Cardiologico Monzino-IRCCS
      • Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Piacenza, Italy, 29121
        • Osp. Guglielmo da Saliceto AUSL di Piacenza
      • Roma, Italy, 00163
        • IRCCS San Raffaele
      • Torino, Italy, 10126
        • AO Città della Salute e della
      • Trieste, Italy, 34124
        • Azienda sanitaria universitaria Giuliano Isontina
  • Japan
      • Fukuoka, Kitakyushu, Japan, 806-8501
        • Japan Community Health care Organization Kyushu Hospital
      • Ibaraki, Higashiibaraki-gun, Japan, 311-3193
        • Mito Medical Center
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
      • Nagano, Matsumoto, Japan, 390-8621
        • Shinshu University Hospital
      • Okayama, Okayama, Japan, 700-0804
        • The Sakakibara Heart Institute of Okayama
      • Osaka, Suita, Japan, 565-0871
        • Osaka University Hospital
      • Saitama, Kawaguchi, Japan, 333-0842
        • Kawaguchi Cardiovascular and Respiratory Hospital
      • Saitama, Sayama, Japan, 350-1305
        • Saitama Sekishikai Hospital
      • Tokyo, Itabashi-ku, Japan, 173-8610
        • Nihon University Itabashi Hospital
  • Netherlands
      • 's HERTOGENBOSCH, Netherlands, 5223 GZ
        • Jeroen Bosch Ziekenhuis-Hertogenbosch
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuizen Apeldoorn
      • Den Haag, Netherlands, 2545 AA
        • Hagaziekenhuis
      • Emmen, Netherlands, 7824 AA
        • TREANT zorggroep
      • Gouda, Netherlands, 2803 HH
        • Groene Hart ziekenhuis
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
      • Harderwijk, Netherlands, 3844 DG
        • Sint Jansdal Ziekenhuis
      • Leiderdorp, Netherlands, 2353 GA
        • Alrijne Leiderdorp
      • Roosendaal, Netherlands, 4708 AE
        • Bravis Ziekenhuis, locatie Roosendaal
      • Utrecht, Netherlands, 3582 KE
        • Diakonessenhuis Utrecht
  • Norway
      • Førde, Norway, N-6812
        • Helse Førde HF, Førde Sentralsjukehus
      • Lillehammer, Norway, N-2609
        • Sykehuset Innlandet HF, Avd. Lillehammer
      • Lørenskog, Norway, N-1478
        • Akershus Universitetssykehus HF
      • Stavanger, Norway, N-4011
        • Helse Stavanger, Stavanger Universitetssykehus
      • Tromsø, Norway, N-9019
        • Universitetssykehuset Nord-Norge, Tromsø
  • Poland
      • Gdynia, Poland, 81348
        • Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia
      • Lodz, Poland, 92-213
        • Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard
      • Lodz, Poland, 93-513
        • Provincial Specialist M. Kopernik Hospital
      • Lodz, Poland, 90549
        • Card.Cli.Mil.Med.Ac.Uni.Cli.Hosp. Cent.Vetera.Hosp.Lodz
  • Spain
      • El Palmar, Spain, 30120
        • Hospital Universitario Virgen de La Arrixaca
      • L'Hospitalet de Llobregat, Spain, 08907
        • Hospital De Bellvitge
      • Majadahonda, Spain, 28222
        • Hospital Puerta de Hierro
      • Malaga, Spain, 29010
        • Hospital Virgen de la Victoria
      • Sant Joan Despi, Spain, 08970
        • Hospital Moisès Broggi
      • Sevilla, Spain, 41014
        • Hospital Nuestra Señora de Valme
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia
  • Sweden
      • Göteborg, Sweden, 416 85
        • Sahlgrenska Universitetssjukhuset, Östra
      • Göteborg, Sweden, 41345
        • Sahlgrenska US, Göteborg
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Orange, California, United States, 92865
        • University of California Irvine
      • Torrance, California, United States, 90502
        • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Cardiology Associates Research Co.
      • Jacksonville, Florida, United States, 32209
        • University of Florida Health Jacksonville
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
    • Illinois
      • Peoria, Illinois, United States, 61603
        • Methodist Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Elmer, New Jersey, United States, 08318
        • Cardiovascular Associates of the Delaware Valley
      • Washington Township, New Jersey, United States, 08080
        • Jefferson Washington Township Hospital
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center
      • Greenvale, New York, United States, 11548
        • The DeMatteis Center for Cardiac Research and Education
      • Stony Brook, New York, United States, 11794
        • Stony Brook Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Heart and Vascular
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • South Oklahoma Heart Research Group
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Ralph H. Johnson VA Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Amarillo, Texas, United States, 79109
        • Pharmatex Research
      • Plano, Texas, United States, 75093
        • Center for Advanced Cardiac Care - Heart Failure Clinic
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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,
    • 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

Exclusion Criteria:

  • 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
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo to Empagliflozin
Film-coated tablet
Experimental: Empagliflozin
Drug: Empagliflozin
Film-coated tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.

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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Improvement of at Least 10 Points in KCCQ-TSS After 90 Days of Treatment
Time Frame: At baseline and at day 90.

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.
At baseline and at day 90.
Change From Baseline in KCCQ-TSS After 90 Days of Treatment
Time Frame: At baseline, at day 15, 30 and at day 90.

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.
At baseline, at day 15, 30 and at day 90.
Change From Baseline in Log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) Area Under the Curve (AUC) Over 30 Days of Treatment
Time Frame: From baseline to day 30.
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.
From baseline to day 30.
Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 30 Days After Initial Hospital Discharge
Time Frame: Up to 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.
Up to 30 days after initial hospital discharge.
Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 90 Days After Randomisation
Time Frame: Up to 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.
Up to 90 days after randomisation.
Incidence Rate of First Occurrence of Cardiovascular (CV) Death or Heart Failure Event (HFE) Until End of Trial Visit
Time Frame: Up to 127 days.

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].
Up to 127 days.
Number of Participants With Hospitalization for Heart Failure (HHF) Until 30 Days After Initial Hospital Discharge
Time Frame: Up to 30 days after initial hospital discharge.
Number of participants with hospitalization for heart failure (HHF) until 30 days after initial hospital discharge.
Up to 30 days after initial hospital discharge.
Composite Renal Endpoint: Number of Participants With Chronic Dialysis, Renal Transplant, Sustained Reduction in eGFR(CKD-EPI)cr
Time Frame: Up to 90 days.

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.
Up to 90 days.
Weight Change Per Mean Daily Loop Diuretic Dose After 15 Days of Treatment
Time Frame: At baseline and at day 15.

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
At baseline and at day 15.
Weight Change Per Mean Daily Loop Diuretic Dose After 30 Days of Treatment
Time Frame: At baseline and at day 30.

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
At baseline and at day 30.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1245-0204
  • 2019-002946-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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