Acute Myocardial Infarction With Right Ventricular Extension Clinical Trial
Official title:
Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction With Right Ventricular Extension: A Multicentric Randomized Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment