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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517977-26-00 | EU Trial (CTIS) Number |
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The goal of this clinical trial is to test the hypothesis that the continuation of empagliflozin during decongestive therapy in the setting of acute decompensated and hospitalized heart failure patients is not inferior compared to therapy cessation during the acute heart failure hospitalization.
Randomized treatment (plus standard medical care) in patients with acute decompensated heart failure is one (1) tablet daily of empagliflozin 10 mg or matching placebo during the in-hospital stay (up to a maximum of 30 days), followed by treatment with empagliflozin 10 mg daily after discharge (but no later than day 31) until day 90.
The primary outcome measure is the combined hierarchical endpoint of all-cause mortality, heart failure hospitalization and worsening renal function at 90 days after admission.
Secondary outcome measures are the effects on urine output, diuretic efficiency, quality-of-life and the need for further administration of diuretics.
Participants will
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Placebo Comparator | Randomized treatment with placebo (one tablet) daily from day 1 until the day of hospital discharge, but no longer than 30 days, followed by 10 mg empagliflozin (Jardiance, one tablet) daily until day 90. |
|
| intervention | Active Comparator | Drug: Empagliflozin (10 mg/day), film-coated tablet Randomized treatment with 10 mg empagliflozin (Jardiance, one tablet) or placebo daily from day 1 until the day of hospital discharge, but no longer than 30 days, followed by 10 mg empagliflozin (Jardiance, one tablet) daily until day 90 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 10 MG Oral Tablet [Jardiance] | Drug | Randomized treatment with 10 mg empagliflozin (Jardiance, one tablet) daily from day 1 until the day of hospital discharge, but no longer than 30 days, followed by 10 mg empagliflozin (Jardiance, one tablet) daily until day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Four-step hierarchical composite primary endpoint; win ratio based on the following parameters (day 90): time to all-cause death, number of heart failure events per patient, time to first heart failure event, eGFR decrease from baseline to day 90 | The study uses a four-step hierarchical composite primary endpoint (win ratio):
| day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular and total mortality on day 90 | day 90 | |
| Number of patients alive and without re-hospitalization on day 90 | day 90 | |
| Re-hospitalization after initial discharge, including reason: time to first rehospitalization after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jena University Hospital | Recruiting | Jena | Thuringia | 07747 | Germany |
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| Placebo | Drug | Randomized treatment with placebo (one tablet) daily from day 1 until the day of hospital discharge, but no longer than 30 days, followed by 10 mg empagliflozin (Jardiance, one tablet) daily until day 90 |
|
| day 90 |
| Re-hospitalization after initial discharge, including reason: numbers of re-hospitalizations | day 90 |
| Number of patients with a decrease in eGFR of 5 ml/min/1.73 m² or more from baseline to day 90 | day 90 |
| Daily and cumulative urine output (UOP, ml) measured from day 1 until day 6 | day 1 until day 6 |
| Diuretic efficiency (ml urine per mg furosemide equivalent) from day 1 to day 6 | day 1 until day 6 |
| Change in body weight from baseline to day 1, day 3, day 6, discharge (supposed between day 6-10), day 30, and day 90 | day 1, day 3, day 6, discharge (supposed between day 6-10), day 30, and day 90 |
| Renal function at baseline, day 3, day 6, day 30, and day 90 |
| baseline, day 3, day 6, day 30, and day 90 |
| Liver function: bilirubin (nmol/ml) at baseline, day 3, day 6, day 30, and day 90 | baseline, day 3, day 6, day 30, and day 90 |
| Liver function: serum aminotransferases (µmol/l*s) at baseline, day 3, day 6, day 30, and day 90 | baseline, day 3, day 6, day 30, and day 90 |
| Liver function: relevant change in coagulation status (Quick/INR, %, 3X upper limit of normal) at baseline, day 3, day 6, day 30, and day 90 | baseline, day 3, day 6, day 30, and day 90 |
| Change in NT-proBNP (N-terminal pro Brain natriuretic peptide, pg/ml) (alternatively calculated from BNP, Brain natriuretic peptide, pg/ml) from baseline to day 6, day 30, and day 90 | baseline to day 6, day 30, and day 90 |
| Quality of life (EQ-5D-3L questionnaire, 3-level version of the EuroQol five dimensional descriptive system ) on day 0, at hospital discharge (supposed between day 6-10), and on day 30 | Quality of life: EQ-5D-3L questionaire. The EQ-5D-3L questionnaire consists of two parts: part one contains questions about patients mobility, self-care, usual activities, pain/discomfort, anxiety/depression, with scores from 1 (no problem), 2 (some problems), and 3 (extreme problems). Part two measures patients health on a scale from 0 (the worst imaginable health) to 100 (the best imaginable health), on day 0, at hospital discharge (supposed between day 6-10), and on day 30 | day 0, at hospital discharge (supposed between day 6-10), and on day 30 |
| Severity of heart failure (HF): KCCQ-12 questionnaire (Kansas City Cardiomyopathy Questionnaire comprising 12 items) on day 0, at hospital discharge (supposed between day 6-10), and on day 30 | KCCQ-12 questionnaire: scores range from 0 to 100, with higher scores indicating better health status, on day 0, at hospital discharge (supposed between day 6-10), and on day 30 | day 0, at hospital discharge (supposed between day 6-10), and on day 30 |
| Intermediate Care Unit (IMC) / Intensive Care Unit (ICU) and hospital length of stay, days until discharge (supposed between day 6-10) | discharge (supposed between day 6-10) |
| Single parameters of primary endpoint: time to all-cause death (day 90) | day 90 |
| Single parameters of primary endpoint: number of heart failure events per patient (day 90) | day 90 |
| Single parameters of primary endpoint: time to first heart failure event (day 90) | day 90 |
| Single parameters of primary endpoint: eGFR decrease from baseline to day 90 (ml/min/1.73 m²) | day 90 |
| Kerckhoff-Klinik GmbH | Recruiting | Bad Nauheim | 61231 | Germany |
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| Herzzentrum Dresden GmbH Universitaetsklinik | Not yet recruiting | Dresden | 01307 | Germany |
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| Universitaetsmedizin Goettingen | Not yet recruiting | Göttingen | 37075 | Germany |
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| Universitaetsklinikum Leipzig AöR | Recruiting | Leipzig | 04103 | Germany |
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| Herzzentrum Leipzig GmbH | Not yet recruiting | Leipzig | 04289 | Germany |
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| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Not yet recruiting | Mainz | 55131 | Germany |
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| LMU Klinikum Muenchen AöR | Not yet recruiting | München | 81377 | Germany |
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| Rostock University Medical Center | Not yet recruiting | Rostock | 18057 | Germany |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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