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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furosemide | Experimental | Furosemide and Placebo filling (Glucose 5%). |
|
| Fluid expansion | Active Comparator | Placebo furosemide (Glucose 5%) and Vascular filling The vascular filling is the gold standard in the treatment of acute myocardial infarction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-hospital mortality | an average of 10 days after inclusion | |
| Rate of inotropic support | an average of 10 days after inclusion | |
| Number of hemodynamic instability requiring fluid expansion |
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Inclusion Criteria
Age >18 years
Inferior acute myocardial infarction (≤J + 7)
Right ventricular extension defined by one following echocardiographic criteria:
Inferior vena cava dilatation (≥20mm) and non-compliant (changes <50%) associated with one hemodynamic instability criteria:
Informed consent for study participation signed.
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pascal Lim, MD, PhD | Contact | (0)1 49 81 45 84 | +33 | lim.pascal.hmn@gmail.com |
| Ludivine Brouard, CRA | Contact | (0)1 49 81 37 53 | +33 | ludivine.brouard@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pascal Lim, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Créteil | 94010 | France |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D004232 | Diuretics |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Placebo filling | Drug | Placebo filling: Glucose 5%, 500mL infused over 30 minutes. |
|
|
| Placebo furosemide | Drug | 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). |
|
|
| Vascular filling | Drug | Vascular filling: Sodium 0.9% 500mL infused over 30 minutes. |
|
|
| an average of 10 days after inclusion |
| Change in systolic blood | Hour 24 |
| Change in heart rate | Hour 24 |
| Urine output | Hour 24 |
| The duration of hospitalization in intensive care | an average of month 1 |
| Hospitalizations for cardiovascular reason one month after acute myocardial infarction | month 1 |
| One month mortality | month 1 |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |