Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure (EMPATHY)

March 7, 2023 updated by: Medical University of Warsaw

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.

Study Overview

Status

Status

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

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 (Anticipated)

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.
1364

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
      • Grodzisk Mazowiecki, Poland
        • Recruiting
        • Autonomous Public Specialist Western John Paul II Hospital
        • Contact:
          • Janusz Bednarski

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:

  • 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,
  • 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

Exclusion Criteria:

  • 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
  • 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

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: Quadruple

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.
Active Comparator: SGLT 2 Inhibitor
Empagliflozin (n=341) or Dapagliflozin (n=341): 9 months of treatment
Drug: Empagliflozin 10 MG
once daily for 6 or 9 months
Other Names:
  • Jardiance
Drug: Dapagliflozin 10 MG
once daily for 6 or 9 months
Other Names:
  • Forxiga
Placebo Comparator: Placebo with a switch to SGLT 2 Inhibitor
Placebo (n=682) for 3 months of treatment with a subsequent switch to Empagliflozin (n=341) or Dapagliflozin (n=341): 6 months of treatment
Drug: Placebo
once daily for 3 months
Other Names:
  • Placebo with switch to SGLT2 inhibitor

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
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
combined endpoint
at 3 and 9 months

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
Difference in the number of recurrent hospitalizations due to heart failure between the treatment groups
Time Frame: at 3 and 9 months
recurrent hospitalizations due to heart failure
at 3 and 9 months
Difference in the number of hospitalizations for CV causes between the treatment groups
Time Frame: at 3 and 9 months
hospitalizations for CV causes
at 3 and 9 months
Difference in the number of hospitalizations for other than CV causes between the treatment groups
Time Frame: at 3 and 9 months
hospitalizations for other than CV causes
at 3 and 9 months
Time to adjudicated CV death
Time Frame: at 3 and 9 months
CV death
at 3 and 9 months
Time to adjudicated all cause death
Time Frame: at 3 and 9 months
all cause death
at 3 and 9 months
Time to adjudicated myocardial infarction
Time Frame: at 3 and 9 months
myocardial infarction
at 3 and 9 months
eGFR (Estimated Glomerular Filtration Rate) (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation)) creatine slope of change from baseline between the treatment groups
Time Frame: at 3 and 9 months
eGFR
at 3 and 9 months
Difference in the number of hospital re-admissions due to heart failure between the treatment groups
Time Frame: at 3 and 9 months
hospital re-admissions due to heart failure
at 3 and 9 months
Difference in the number of hospital re-admissions for any cause between the treatment groups
Time Frame: at 3 and 9 months
hospital re-admissions for any cause
at 3 and 9 months
Difference in the duration of hospital stay between the treatment groups after initiation of the study treatment
Time Frame: at 3 and 9 months
duration of hospital stay
at 3 and 9 months
Difference in the number of incidences of new onset AF and re-occurrence of AF between treatment groups
Time Frame: at 3 and 9 months
new onset AF
at 3 and 9 months
Difference in the change of ejection fraction in echocardiography between treatment groups
Time Frame: at 3 and 9 months
ejection fraction
at 3 and 9 months
Difference in the change of left ventricular diastolic function in echocardiography
Time Frame: at 3 and 9 months
left ventricular diastolic function
at 3 and 9 months
Difference in the change of LV strain analysis in echocardiography
Time Frame: at 3 and 9 months
LV strain
at 3 and 9 months
The time-averaged proportional change in NT-proBNP from
Time Frame: at 3 and 9 months
NT-proBNP
at 3 and 9 months
The time-averaged proportional change in selected miRNA expression linked to hypertrophy, inflammation, fibrosis, apoptosis, electric stability between treatment groups and placebo group
Time Frame: at 3 and 9 months
miRNA expression
at 3 and 9 months
The time-averaged proportional change in pre-specified biomarkers
Time Frame: at 3 and 9 months
biomarkers
at 3 and 9 months
Change from baseline in clinical summary score (HF (Chronic Heart Failure) symptoms and physical limitations domains) of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: at 3 and 9 months
HF score
at 3 and 9 months

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.
Medical University of Warsaw

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.
Medical University of Graz
Medical University of Vienna
Poznan University of Medical Sciences
Medical University of Gdansk
University Clinical Center of the Medical University of Warsaw
Jerzy Popiełuszko Bielański Hospital in Warsaw
Regional Polyclinical Hospital in Kielce
University Clinical Hospital Military Medical Academy, Central Veterans Hospital in Łódź
Autonomous Public Specialist Western John Paul II Hospital in Grodzisk Mazowiecki
Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
John Paul II Specialist Hospital in Kraków
Ludwik Rydygier Regional Polyclinical Hospital in Toruń
University Teaching Hospital in Białystok
Medical University of Silesia in Katowice

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.
March 15, 2022

Primary Completion (Anticipated)

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.
September 30, 2024

Study Completion (Anticipated)

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.
December 31, 2025

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).
April 4, 2022

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.
March 7, 2023

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.
March 20, 2023

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.
March 20, 2023

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.
March 7, 2023

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.
March 1, 2023

More Information

Terms related to this study

Keywords

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.
  • EMPATHY
  • 2020-003497-48 (EudraCT Number)
  • 2019/ABM/01/00037 (Other Grant/Funding Number: Medical Research Agency (ABM))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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