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LEONARD.LEvOsimendaN vs. Placebo Before Tricuspid VAlve Surgery in Patients with Right Ventricular Dysfunction (LEONARD)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516167-86-00
Acronym
APHP200072
Enrollment
230
Registered
2024-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-22

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

Conditions

Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid regurgitation

Brief summary

The primary end point is a composite element reflecting low cardiac output syndrome at 90 days: - 1) Catecholamine infusion persisting beyond 48 hours after cardiac surgery, - 2) Need for circulatory mechanical assist devices in the postoperative period, - 3) Need for renal replacement therapy at any time during intensive care unit stay.

Detailed description

1) Mortality at day 90, 2) Each component of the primary end point, 3) The study drug safety was assessed by recording of the incidence refractory hypotension was defined as a failure to increase mean arterial pressure above 60 mmHg despite optimal management.

Interventions

DRUGPlacebo of ZIMINO (glucose 5%)
DRUGsolution à diluer pour perfusion

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary end point is a composite element reflecting low cardiac output syndrome at 90 days: - 1) Catecholamine infusion persisting beyond 48 hours after cardiac surgery, - 2) Need for circulatory mechanical assist devices in the postoperative period, - 3) Need for renal replacement therapy at any time during intensive care unit stay.

Secondary

MeasureTime frame
1) Mortality at day 90, 2) Each component of the primary end point, 3) The study drug safety was assessed by recording of the incidence refractory hypotension was defined as a failure to increase mean arterial pressure above 60 mmHg despite optimal management.

Countries

France

Outcome results

None listed

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