Myocardial infarction with right ventricular extension. MedDRA version: 19.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Furosémide Renaudin
Product Name: Furosémide Renaudin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Furosémide
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >18 years Inferior acute myocardial infarction ( 0.9) o RV dysfunction defined by TAPSE =20mm) and non-compliant (changes =65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
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 40mmHg), mitral or aortic regurgitation grade >=3 - Severe left ventricular dysfunction defined by an LVEF 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, curatorship) - Inability or refusal to understand or refusal to sign the informed consent from study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.; Secondary Objective: Secondary objectives are: Evaluate the efficacy (clinical benefit) of furosemide. Observe the effect of treatments on improving cardiac index and diastolic function via an echography by Doppler method. Compare the duration of hospitalization in intensive care. Assess the safety of furosemide. Assess the post-infarction survival at one month of hospitalization. ;Primary end point(s): The primary endpoint is compare the change in cardiac output in patients admitted and treated by either fluid expansion or furosemide.;Timepoint(s) of evaluation of this end point: Between H24-H30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will evaluate the safety and clinical benefit via: Intra-hospital mortality Rate of inotropic support Hemodynamic instability requiring fluid expansion Change in systolic blood at 24 hours Change in heart rate at 24 hours Urine output at 24 hours The duration of hospitalization in intensive care Hospitalizations for cardiovascular reason one month after acute myocardial infarction One month mortality ;Timepoint(s) of evaluation of this end point: between H24 and 1 month | — |
Countries
France
Contacts
Public ContactDRCD Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed