Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction (FAMIE)
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|ClinicalTrials.gov Identifier: NCT02905760|
Recruitment Status : Unknown
Verified July 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Not yet recruiting
First Posted : September 19, 2016
Last Update Posted : September 19, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction With Right Ventricular Extension||Drug: Furosemide Drug: Placebo filling Drug: Placebo furosemide Drug: Vascular filling||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction With Right Ventricular Extension: A Multicentric Randomized Controlled Trial|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||January 2019|
Furosemide and Placebo filling (Glucose 5%).
Furosemide: Special LASILIX (250 mg/25 ml) solution for injection reconditioned glass bottle like "penicillin" of 80mg/8mL. Injection by slow intravenous (1 to 2 minutes per 80mg vial)
Other Name: Diuretics, LASILIX.
Drug: Placebo filling
Placebo filling: Glucose 5%, 500mL infused over 30 minutes.
Other Name: G5
Active Comparator: Fluid expansion
Placebo furosemide (Glucose 5%) and Vascular filling
The vascular filling is the gold standard in the treatment of acute myocardial infarction
Drug: Placebo furosemide
Placebo furosemide: glucose 5% for injection reconditioned glass bottle like "penicillin" of 80mg/8mL. Injection by slow intravenous (1 to 2 minutes per 80mg vial).
Other Name: G5
Drug: Vascular filling
Vascular filling: Sodium 0.9% 500mL infused over 30 minutes.
Other Name: Fluid expansion, Sodium Chloride NaCl 0.9%.
- 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. [ Time Frame: At Hour 24 ]
- Intra-hospital mortality [ Time Frame: an average of 10 days after inclusion ]
- Rate of inotropic support [ Time Frame: an average of 10 days after inclusion ]
- Number of hemodynamic instability requiring fluid expansion [ Time Frame: an average of 10 days after inclusion ]
- Change in systolic blood [ Time Frame: Hour 24 ]
- Change in heart rate [ Time Frame: Hour 24 ]
- Urine output [ Time Frame: Hour 24 ]
- The duration of hospitalization in intensive care [ Time Frame: an average of month 1 ]
- Hospitalizations for cardiovascular reason one month after acute myocardial infarction [ Time Frame: month 1 ]
- One month mortality [ Time Frame: month 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905760
|Contact: Pascal Lim, MD, PhD||(0)1 49 81 45 84 ext +firstname.lastname@example.org|
|Contact: Ludivine Brouard, CRA||(0)1 49 81 37 53 ext +email@example.com|
|Henri Mondor Hospital||Not yet recruiting|
|Creteil, France, 94010|
|Principal Investigator:||Pascal Lim, MD, PhD||Assistance Publique - Hôpitaux de Paris|