Acute Myocardial Infarction With Right Ventricular Extension Clinical Trial
— FAMIEOfficial 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.
| Status | Not yet recruiting |
| Enrollment | 88 |
| Est. completion date | January 2019 |
| Est. primary completion date | November 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Henri Mondor Hospital | Creteil |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | Intra-hospital mortality | an average of 10 days after inclusion | No | |
| Secondary | Rate of inotropic support | an average of 10 days after inclusion | No | |
| Secondary | Number of hemodynamic instability requiring fluid expansion | an average of 10 days after inclusion | No | |
| Secondary | Change in systolic blood | Hour 24 | No | |
| Secondary | Change in heart rate | Hour 24 | No | |
| Secondary | Urine output | Hour 24 | No | |
| Secondary | The duration of hospitalization in intensive care | an average of month 1 | No | |
| Secondary | Hospitalizations for cardiovascular reason one month after acute myocardial infarction | month 1 | No | |
| Secondary | One month mortality | month 1 | No |