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

Assistance Publique - Hôpitaux de Paris

Status and phase: Unknown; Phase 3

Conditions: Acute Myocardial Infarction With Right Ventricular Extension

Treatments: Drug: Vascular filling; Drug: Placebo filling; Drug: Furosemide; Drug: Placebo furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT02905760

P150801

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age >18 years

• Inferior acute myocardial infarction (≤J + 7)

• Right ventricular extension defined by one following echocardiographic criteria:

  • Dilatation of the right ventricle (RV/LV area> 0.9)
  • RV dysfunction defined by TAPSE <16mm or S velocity <10cm.s-1
  • Akinesia or hypokinesia of two contiguous segments of the right ventricle
  • Decrease of pitch on lung failure flow <150ms

• Inferior vena cava dilatation (≥20mm) and non-compliant (changes <50%) associated with one hemodynamic instability criteria:

  • Oliguria (diuresis <800mL/24h or 0.5mL/kg/min)
  • Systolic blood pressure <100mmHg
  • Oxygen saturation <91% on room air
  • Bradycardia (heart rate <60/min, not valid for patients on beta-blockers).

• Informed consent for study participation signed.

Exclusion Criteria

• Minor and pregnant woman
• Mechanical complications of myocardial infarct
• Patients who received> 40mg diuretic /day during the last 15 days
• Hypersensitivity to furosemide or any of its excipients
• Aortic stenosis (area <1 cm² or mean gradient> 40mmHg), mitral or aortic regurgitation grade ≥3
• Catecholamine support for left ventricular failure with left ventricular ejection fraction <35%
• Renal impairment defined by a serum creatinine> 200μmol / mL
• Sodium and water retention
• Urinary tract obstruction
• Hypovolemia or dehydration
• Severe hypokalemia (K + <3 mmol / L)
• Severe hyponatremia (Na + <125 mmol / L)
• Hepatitis ongoing, liver failure or hepatic encephalopathy
• No affiliation to a social security scheme or other social protection scheme
• Private Patient of liberty or under legal protection (guardianship)
• Inability or refusal to understand or refusal to sign the informed consent from study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups

Furosemide

Experimental group

Description:

Furosemide and Placebo filling (Glucose 5%).

Treatment:

Drug: Furosemide

Drug: Placebo filling

Fluid expansion

Active Comparator group

Description:

Placebo furosemide (Glucose 5%) and Vascular filling The vascular filling is the gold standard in the treatment of acute myocardial infarction

Treatment:

Drug: Placebo furosemide

Drug: Vascular filling