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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02905760
Recruitment Status : Unknown
Verified July 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE July 31, 2016
First Posted Date  ICMJE September 19, 2016
Last Update Posted Date September 19, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
  • Intra-hospital mortality [ Time Frame: an average of 10 days after inclusion ]
  • Rate of inotropic support [ Time Frame: an average of 10 days after inclusion ]
  • Number of hemodynamic instability requiring fluid expansion [ Time Frame: an average of 10 days after inclusion ]
  • Change in systolic blood [ Time Frame: Hour 24 ]
  • Change in heart rate [ Time Frame: Hour 24 ]
  • Urine output [ Time Frame: Hour 24 ]
  • The duration of hospitalization in intensive care [ Time Frame: an average of month 1 ]
  • Hospitalizations for cardiovascular reason one month after acute myocardial infarction [ Time Frame: month 1 ]
  • One month mortality [ Time Frame: month 1 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction
Official Title  ICMJE Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction With Right Ventricular Extension: A Multicentric Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction With Right Ventricular Extension
Intervention  ICMJE
  • Drug: Furosemide
    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)
    Other Name: Diuretics, LASILIX.
  • Drug: Placebo filling
    Placebo filling: Glucose 5%, 500mL infused over 30 minutes.
    Other Name: G5
  • Drug: Placebo furosemide
    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).
    Other Name: G5
  • Drug: Vascular filling
    Vascular filling: Sodium 0.9% 500mL infused over 30 minutes.
    Other Name: Fluid expansion, Sodium Chloride NaCl 0.9%.
Study Arms  ICMJE
  • Experimental: Furosemide
    Furosemide and Placebo filling (Glucose 5%).
    Interventions:
    • Drug: Furosemide
    • Drug: Placebo filling
  • Active Comparator: Fluid expansion

    Placebo furosemide (Glucose 5%) and Vascular filling

    The vascular filling is the gold standard in the treatment of acute myocardial infarction

    Interventions:
    • Drug: Placebo furosemide
    • Drug: Vascular filling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 16, 2016)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02905760
Other Study ID Numbers  ICMJE P150801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pascal Lim, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP