drugset / Trial / NCT02905760

Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction

NCT02905760

Phase 3 Unknown 88 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Right ventricular necrosis increases patient in hospital mortality and can be observed in 20-50% of patients admitted for during acute myocardial infarction. Current guidelines recommend managing cardiogenic shock related to right ventricular necrosis by optimizing RV load using fluid expansion and if insufficient adding inotropic support. However, several experimental studies reported a potential deleterious effect of right ventricular dilation related to fluid expansion because right and left ventricular interaction decreases stroke volume and cardiac output. Consistently with these finding, a study on a small patient sample conducted at Henri Mondor Hospital demonstrates the safety and efficiency of furosemide in patients with right ventricular necrosis. The present study is a phase 3, interventional, prospective, randomized, multicenter, double-blind analysis by intention to treat. The main objective is to demonstrate improved hemodynamic parameters in the short term in patients admitted for acute myocardial infarction with extension RV treated with furosemide. The primary endpoint is compare the change in cardiac output in patients admitted and treated by either fluid expansion or furosemide. The study population will consist in 88 patients and the duration of subjects' participation will be one month.

Timeline

Start
2016-12
Primary completion
2018-11
Completion
2019-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Furosemide Other / unclassified 80 mg Intravenous
Subject sodium chloride Unknown 500 ml