NCT03699215

Clinical Trial in Patients Who Have Suffered a Heart Attack and Who Have Undergone Catheterization Treated With Levosimendan

Ensayo clínico, Fase III, Aleatorizado, Prospectivo, unicéntrico, Doble Ciego y Controlado Con Placebo, Para Estimar la Eficacia y Seguridad Del Levosimendan Intravenoso, en Las Primeras 24 Horas Tras la Angioplastia Primaria, en Pacientes Con síndrome Coronario Agudo Con elevación Del Segmento ST

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Hospital Universitario de Canarias · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The disease under study is acute coronary syndrome with ST segment elevation, defined as patients presenting chest pain of anginal characteristics of more than 20 minutes of duration, with changes in the electrocardiogram consisting of ST segment elevation of 1 mm in two contiguous limb leads or 2 mm in two contiguous leads precordial. In a review carried out on patients treated in the investigator center with SCACEST, invetsigators found that, in a cohort of 250 patients, 85% of them presented alterations Segments of left ventricular contractility at 4 months after the acute episode. To verify that the Levosimendan administration reduces that percentage, at least 65%, investigators require to include in the study 83 patients in the experimental group and 83 in the control group, for a power of 80% and a confidence level of 95%. Assuming 10% of lost patients, it is required to include in the study 92 patients in the experimental group and 92 patients in the group control .

Detailed description

The patients will be included randomly, until the calculated sample size is completed. A recruitment period of 12 months is estimated from the beginning of the study. From the date of inclusion of the first patient, the final duration of the study will be 1.5 years. The study will end when performing the last cardio-resonance and echocardiography that should be performed 6 months after the inclusion of the last patient in the study. Upon arrival of the patient at the Coronary Unit, he will receive, in a randomized and double-blind manner, without a loading dose, the 24-hour infusion of Levosimendan, or placebo. The continuous infusion of levosimendan 0.1 micrograms / kg / min will be administered during 24h. If the initial dose is tolerated and a greater hemodynamic effect is needed, the infusion rate can be increased to 0.2 micrograms / kg / min. The dose of Levosimendan infusion can be reduced to 0.05 μg / kg / min in case of clinical intolerance or systolic hypotension \<90 mmHg. Continuous perfusion of the placebo 0.1 micrograms / kg / min will be administered for 24h. If the initial dose is tolerated and a greater hemodynamic effect is needed, the infusion rate can be increased to 0.2 micrograms / kg / min. The dose of infusion of the placebo can be reduced to 0.05 μg / kg / min in case of clinical intolerance or systolic hypotension \<90 mmHg.

Conditions

• ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Levosimendan	Upon arrival of the patient in the Coronary Unit, he will receive, in a randomized and double-blind manner, the 24-hour infusion of Levosimendan, without a loading dose, at a dose of 0.1 μg / kg / min or placebo. If the initial dose is tolerated and a greater hemodynamic effect is needed, the infusion rate can be increased to 0.2 micrograms / kg / min. The dose of Levosimendan infusion can be reduced to 0.05 μg / kg / min in case of clinical intolerance or systolic hypotension \<90 mmHg.
DRUG	Placebos	continuous perfusion of 0.1 micrograms / kg / min for 24h. If the initial dose is tolerated and a greater hemodynamic effect is needed, the infusion rate can be increased to 0.2 micrograms / kg / min.

Timeline

• Start date: 2018-11-17
• Primary completion: 2020-04-30
• Completion: 2021-12-30
• First posted: 2018-10-09
• Last updated: 2021-02-11

Locations

1 site across 1 country: Spain