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Effect at 3 months of early empagliflozin initiation in cardiogenic shock patients on mortality, rehospitalization, left ventricular ejection fraction and renal function. A randomized multicentric open trial. (EMPASHOCK)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503602-37-00
Acronym
2021PI218
Enrollment
164
Registered
2024-04-09
Start date
2024-12-16
Completion date
Unknown
Last updated
2025-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic Shock

Brief summary

Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): - Rank 1: time to all-cause death or heart transplant or mechanical ventricular assist. - Rank 2: time to rehospitalization for heart failure - Rank 3: left ventricular ejection fraction assessed by echocardiography

Detailed description

Death at 12 weeks, Heart transplantation or long-term ventricular assistance at 12 weeks, Rehospitalization for heart failure from hospital discharge to 12-week, Left ventricular ejection fraction at 12 weeks, Left ventricular relaxation and filling pressures assessed at 12 weeks: e' wave, E/e' ratio,, Right ventricular function assessed at 12 weeks: TAPSE, S wave, Number of patients requiring extra-renal purification between randomization and 12 weeks, and evolution of renal function assessed at randomization and at 12 weeks: glomerular filtration rate calculated by the CKD-EPI method, Liver function assessed at randomization and at 12 weeks: Bilirubin, Prothrombin Ratio , SGOT, SGPT., Weight and NT-proBNP (at randomization and at 12 weeks).

Interventions

DRUGJardiance 10 mg film-coated tablets

Sponsors

CHRU De Nancy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Hierarchical composite endpoint, assessed at 12 weeks from randomization (win-ratio method): - Rank 1: time to all-cause death or heart transplant or mechanical ventricular assist. - Rank 2: time to rehospitalization for heart failure - Rank 3: left ventricular ejection fraction assessed by echocardiography

Secondary

MeasureTime frame
Death at 12 weeks, Heart transplantation or long-term ventricular assistance at 12 weeks, Rehospitalization for heart failure from hospital discharge to 12-week, Left ventricular ejection fraction at 12 weeks, Left ventricular relaxation and filling pressures assessed at 12 weeks: e' wave, E/e' ratio,, Right ventricular function assessed at 12 weeks: TAPSE, S wave, Number of patients requiring extra-renal purification between randomization and 12 weeks, and evolution of renal function assessed at randomization and at 12 weeks: glomerular filtration rate calculated by the CKD-EPI method, Liver function assessed at randomization and at 12 weeks: Bilirubin, Prothrombin Ratio , SGOT, SGPT., Weight and NT-proBNP (at randomization and at 12 weeks).

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026