Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure
NCT ID: NCT05776043
Last Updated: 2023-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1364 participants
INTERVENTIONAL
2022-03-15
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SGLT 2 Inhibitor
Empagliflozin (n=341) or Dapagliflozin (n=341): 9 months of treatment
Empagliflozin 10 MG
once daily for 6 or 9 months
Dapagliflozin 10 MG
once daily for 6 or 9 months
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
Placebo
once daily for 3 months
Interventions
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Empagliflozin 10 MG
once daily for 6 or 9 months
Dapagliflozin 10 MG
once daily for 6 or 9 months
Placebo
once daily for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Medical University of Graz
OTHER
University Clinical Center of the Medical University of Warsaw
UNKNOWN
Jerzy Popiełuszko Bielański Hospital in Warsaw
UNKNOWN
Regional Polyclinical Hospital in Kielce
UNKNOWN
University Clinical Hospital Military Medical Academy, Central Veterans Hospital in Łódź
UNKNOWN
Medical University of Gdansk
OTHER
Autonomous Public Specialist Western John Paul II Hospital in Grodzisk Mazowiecki
UNKNOWN
Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz
OTHER
Poznan University of Medical Sciences
OTHER
John Paul II Hospital, Krakow
OTHER
Ludwik Rydygier Regional Polyclinical Hospital in Toruń
UNKNOWN
University Teaching Hospital in Białystok
UNKNOWN
Medical University of Silesia in Katowice
UNKNOWN
Medical University of Warsaw
OTHER
Responsible Party
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Locations
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Autonomous Public Specialist Western John Paul II Hospital
Grodzisk Mazowiecki, , Poland
Countries
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Central Contacts
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Facility Contacts
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Janusz Bednarski
Role: primary
Other Identifiers
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2020-003497-48
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2019/ABM/01/00037
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EMPATHY
Identifier Type: -
Identifier Source: org_study_id
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