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

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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

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.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction With Right Ventricular Extension Drug: Furosemide Drug: Placebo filling Drug: Placebo furosemide Drug: Vascular filling Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction With Right Ventricular Extension: A Multicentric Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: Furosemide
Furosemide and Placebo filling (Glucose 5%).
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

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

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%.




Primary Outcome Measures :
  1. 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 Measures :
  1. Intra-hospital mortality [ Time Frame: an average of 10 days after inclusion ]
  2. Rate of inotropic support [ Time Frame: an average of 10 days after inclusion ]
  3. Number of hemodynamic instability requiring fluid expansion [ Time Frame: an average of 10 days after inclusion ]
  4. Change in systolic blood [ Time Frame: Hour 24 ]
  5. Change in heart rate [ Time Frame: Hour 24 ]
  6. Urine output [ Time Frame: Hour 24 ]
  7. The duration of hospitalization in intensive care [ Time Frame: an average of month 1 ]
  8. Hospitalizations for cardiovascular reason one month after acute myocardial infarction [ Time Frame: month 1 ]
  9. One month mortality [ Time Frame: month 1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905760


Contacts
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Contact: Pascal Lim, MD, PhD (0)1 49 81 45 84 ext +33 lim.pascal.hmn@gmail.com
Contact: Ludivine Brouard, CRA (0)1 49 81 37 53 ext +33 ludivine.brouard@aphp.fr

Locations
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France
Henri Mondor Hospital Not yet recruiting
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Pascal Lim, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02905760     History of Changes
Other Study ID Numbers: P150801
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute Myocardial Infarction
Right ventricular infarction
Diuretic
Fluid Expansion
Additional relevant MeSH terms:
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Furosemide
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action