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

Primary Purpose

Acute Myocardial Infarction With Right Ventricular Extension

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Furosemide
Placebo filling
Placebo furosemide
Vascular filling
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction With Right Ventricular Extension focused on measuring Acute Myocardial Infarction, Right ventricular infarction, Diuretic, Fluid Expansion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henri Mondor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Furosemide

Fluid expansion

Arm Description

Furosemide and Placebo filling (Glucose 5%).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intra-hospital mortality
Rate of inotropic support
Number of hemodynamic instability requiring fluid expansion
Change in systolic blood
Change in heart rate
Urine output
The duration of hospitalization in intensive care
Hospitalizations for cardiovascular reason one month after acute myocardial infarction
One month mortality

Full Information

First Posted
July 31, 2016
Last Updated
September 16, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02905760
Brief Title
Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction
Acronym
FAMIE
Official Title
Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction With Right Ventricular Extension: A Multicentric Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction With Right Ventricular Extension
Keywords
Acute Myocardial Infarction, Right ventricular infarction, Diuretic, Fluid Expansion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Furosemide
Arm Type
Experimental
Arm Description
Furosemide and Placebo filling (Glucose 5%).
Arm Title
Fluid expansion
Arm Type
Active Comparator
Arm Description
Placebo furosemide (Glucose 5%) and Vascular filling The vascular filling is the gold standard in the treatment of acute myocardial infarction
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Diuretics, LASILIX.
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo filling
Other Intervention Name(s)
G5
Intervention Description
Placebo filling: Glucose 5%, 500mL infused over 30 minutes.
Intervention Type
Drug
Intervention Name(s)
Placebo furosemide
Other Intervention Name(s)
G5
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Vascular filling
Other Intervention Name(s)
Fluid expansion, Sodium Chloride NaCl 0.9%.
Intervention Description
Vascular filling: Sodium 0.9% 500mL infused over 30 minutes.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Intra-hospital mortality
Time Frame
an average of 10 days after inclusion
Title
Rate of inotropic support
Time Frame
an average of 10 days after inclusion
Title
Number of hemodynamic instability requiring fluid expansion
Time Frame
an average of 10 days after inclusion
Title
Change in systolic blood
Time Frame
Hour 24
Title
Change in heart rate
Time Frame
Hour 24
Title
Urine output
Time Frame
Hour 24
Title
The duration of hospitalization in intensive care
Time Frame
an average of month 1
Title
Hospitalizations for cardiovascular reason one month after acute myocardial infarction
Time Frame
month 1
Title
One month mortality
Time Frame
month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal Lim, MD, PhD
Phone
(0)1 49 81 45 84
Ext
+33
Email
lim.pascal.hmn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ludivine Brouard, CRA
Phone
(0)1 49 81 37 53
Ext
+33
Email
ludivine.brouard@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Lim, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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