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

Phase 3

• Conditions: Acute Myocardial Infarction With Right Ventricular Extension
• Interventions: Drug: Furosemide; Drug: Placebo furosemide; Drug: Placebo filling; Drug: Vascular filling

• Registration Number: NCT02905760
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study First Submitted: 2016-07-31
• Study First Submitted QC: 2016-09-16
• Last Update Submitted: 2016-09-16
• Study First Posted: 2016-09-19
• Last Update Posted: 2016-09-19
• Study Start: 2016-12
• Primary Completion: 2018-11
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Furosemide	Furosemide	Furosemide and Placebo filling (Glucose 5%).
Furosemide	Placebo filling	Furosemide and Placebo filling (Glucose 5%).
Fluid expansion	Placebo furosemide	Placebo furosemide (Glucose 5%) and Vascular filling The vascular filling is the gold standard in the treatment of acute myocardial infarction
Fluid expansion	Vascular filling	Placebo furosemide (Glucose 5%) and Vascular filling The vascular filling is the gold standard in the treatment of acute myocardial infarction

Primary Outcome Measures

Name	Time	Method
Improvement in cardiac output (measured by Doppler method) defined by an increase of more than 10% 24 hours after administration of the treatment in patients admitted and treated by either fluid expansion or furosemide.	At Hour 24

Secondary Outcome Measures

Name	Time	Method
Hospitalizations for cardiovascular reason one month after acute myocardial infarction	month 1
Rate of inotropic support	an average of 10 days after inclusion
Change in systolic blood	Hour 24
Number of hemodynamic instability requiring fluid expansion	an average of 10 days after inclusion
Change in heart rate	Hour 24
Urine output	Hour 24
Intra-hospital mortality	an average of 10 days after inclusion
One month mortality	month 1
The duration of hospitalization in intensive care	an average of month 1

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France