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AzTrials

Acute Decompensated Heart FailurePhase 3EMPATHYNCT05776043

Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure

A Phase 3 study testing Empagliflozin 10 MG and Dapagliflozin 10 MG in people with Acute Decompensated Heart Failure, run by Medical University of Warsaw at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

National, multicenter, randomized, double-blind, parallel-group, stratified by SGLT-2 inhibitor type, placebo-controlled trial, - a Phase III study. Primary objective of the study is to investigate the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on clinical endpoints in patients hospitalized with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Decompensated Heart Failure
What is being tested?
Empagliflozin 10 MG and Dapagliflozin 10 MG
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,364 participants
Where
1 sitePoland
Study dates
15 Mar 2022to 31 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Patients 18 years of age with the capacity to provide written informed consent
  • Currently hospitalized for a primary diagnosis of acute/decompensated HF (HFrEF, HFmrEF,HFpEF), including symptoms and signs of fluid overload regardless of ejection fraction or diabetes status
  • In patients with HFpEF the diagnosis has to be confirmed according to the current HFpEF definition (by non-invasive testing: evidence of structural or functional changes in the heart as evidenced on echocardiography or by invasive testing as LVEDP assessment or right heart catheterisation).
  • Randomized no earlier than 24 hours and up to 10 days after initial presentation while still hospitalized
  • Stable as defined by: systolic blood pressure (SBP>100 mmHg for the preceding 6 hours)
  • No intensification of IV diuretics within the last 6 hours,
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  • No use of IV vasodilators within the last 6 hours,
  • No use of IV inotropes or levosimendan within the last 24 hours prior to randomization
  • Elevated NT-proBNP >600 pg/mL during the current hospitalization in patients with HFrEF and >300 pg/mL in patients with HFmrEF or HFpEF (or above 900 pg/ml if atrial fibrillation is present at admission independently from EF).
  • eGFR >20 ml/min/1,73m2

Who cannot join

  • History of ketoacidosis
  • Type 1 diabetes
  • SGLT-2 Inhibitor at baseline or known allergy to SGLT-2 Inhibitors
  • Current active cancer with less than 2 years of life expectancy
  • Pulmonary embolism, cerebrovascular accident as the primary trigger for the current hospitalization
  • Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction
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  • Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
  • Blood pH<7.32
  • >1 episode of severe hypoglycaemia within the last 6 months under treatment with insulin or sulfonylurea
  • Acute symptomatic urinary tract infection or genital infection

Trial locations and contacts

1 site in 1 country.

Prof. Marek Postula, MD PhD contact

0048 22 1166160

mpostula@wum.edu.pl

Prof. Jolanta M. Siller-Matula, MD PhD contact

Jolanta.Siller-Matula@meduniwien.ac.at

Poland1 site, 1 recruiting

  • Autonomous Public Specialist Western John Paul II Hospital

    Grodzisk Mazowiecki

    Janusz Bednarski

    Recruiting

Other trials in Poland

About this study

Official title: Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure (EMPATHY) - a Phase III Trial.

National, multicenter, randomized, double-blind, parallel-group, stratified by SGLT-2 inhibitor type, placebo-controlled trial, - a Phase III study. Primary objective of the study is to investigate the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on clinical endpoints in patients hospitalized with acute/decompensated HF.

Being tested
Empagliflozin 10 MG, Dapagliflozin 10 MG, Placebo
Keywords
SGLT-2 inhibitors, dapagliflozin, empagliflozin, acute heart failure, decompensated heart failure

What participants receive

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

  • Empagliflozin 10 MGDrug

    Also called Jardiance

    once daily for 6 or 9 months

  • Dapagliflozin 10 MGDrug

    Also called Forxiga

    once daily for 6 or 9 months

  • PlaceboDrug

    Also called Placebo with switch to SGLT2 inhibitor

    once daily for 3 months

Study groups in NCT05776043
Study groupRoleWhat they receive
SGLT 2 InhibitorActive comparatorEmpagliflozin (n=341) or Dapagliflozin (n=341): 9 months of treatment
Receives: Drug: Empagliflozin 10 MG; Drug: Dapagliflozin 10 MG
Placebo with a switch to SGLT 2 InhibitorPlacebo comparatorPlacebo (n=682) for 3 months of treatment with a subsequent switch to Empagliflozin (n=341) or Dapagliflozin (n=341): 6 months of treatment
Receives: Drug: Placebo

What is being measured

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

  1. Time to first event of adjudicated cardiovascular (CV) death, or adjudicated hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF)

    combined endpoint

    Measured: at 3 and 9 months

Secondary outcomes (18)

  1. Difference in the number of recurrent hospitalizations due to heart failure between the treatment groups

    recurrent hospitalizations due to heart failure

    Measured: at 3 and 9 months

  2. Difference in the number of hospitalizations for CV causes between the treatment groups

    hospitalizations for CV causes

    Measured: at 3 and 9 months

  3. Difference in the number of hospitalizations for other than CV causes between the treatment groups

    hospitalizations for other than CV causes

    Measured: at 3 and 9 months

  4. Time to adjudicated CV death

    CV death

    Measured: at 3 and 9 months

  5. Time to adjudicated all cause death

    all cause death

    Measured: at 3 and 9 months

  6. Time to adjudicated myocardial infarction

    myocardial infarction

    Measured: at 3 and 9 months

  7. eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation)) creatine slope of change from baseline between the treatment groups

    eGFR

    Measured: at 3 and 9 months

  8. Difference in the number of hospital re-admissions due to heart failure between the treatment groups

    hospital re-admissions due to heart failure

    Measured: at 3 and 9 months

  9. Difference in the number of hospital re-admissions for any cause between the treatment groups

    hospital re-admissions for any cause

    Measured: at 3 and 9 months

  10. Difference in the duration of hospital stay between the treatment groups after initiation of the study treatment

    duration of hospital stay

    Measured: at 3 and 9 months

  11. Difference in the number of incidences of new onset AF and re-occurrence of AF between treatment groups

    new onset AF

    Measured: at 3 and 9 months

  12. Difference in the change of ejection fraction in echocardiography between treatment groups

    ejection fraction

    Measured: at 3 and 9 months

  13. Difference in the change of left ventricular diastolic function in echocardiography

    left ventricular diastolic function

    Measured: at 3 and 9 months

  14. Difference in the change of LV strain analysis in echocardiography

    LV strain

    Measured: at 3 and 9 months

  15. The time-averaged proportional change in NT-proBNP from

    NT-proBNP

    Measured: at 3 and 9 months

  16. The time-averaged proportional change in selected miRNA expression linked to hypertrophy, inflammation, fibrosis, apoptosis, electric stability between treatment groups and placebo group

    miRNA expression

    Measured: at 3 and 9 months

  17. The time-averaged proportional change in pre-specified biomarkers

    biomarkers

    Measured: at 3 and 9 months

  18. Change from baseline in clinical summary score (HF (Chronic Heart Failure) symptoms and physical limitations domains) of the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    HF score

    Measured: at 3 and 9 months

Timeline

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

  1. First posted20 Mar 2023
  2. Study start15 Mar 2022
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

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
Model description
Two arms with a subsequent stratification based on the SGLT2 inhibitor type.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05776043
Sponsor's protocol ID
EMPATHY
Other IDs
2020-003497-48, 2019/ABM/01/00037
Acronym
EMPATHY
Status last verified
Mar 2023
First submitted
4 Apr 2022
Last updated
20 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin 10 MG and Dapagliflozin 10 MG in people with Acute Decompensated Heart Failure, run by Medical University of Warsaw at 1 site in Poland.

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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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?

Results are not available in the source record.

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

Contact Prof. Marek Postula, MD PhD (0048 22 1166160, mpostula@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first event of adjudicated cardiovascular (CV) death, or adjudicated hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF) (time frame: at 3 and 9 months). 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 NCT05776043.

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 20 Mar 2023.

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