Clinical trial NCT02905760: Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Myocardial Infarction With Right Ventricular Extension
Keywords: Acute Myocardial Infarction
Right ventricular infarction
Diuretic
Fluid Expansion
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: At Hour 24
Secondary outcomes:
measure: Intra-hospital mortality
timeFrame: an average of 10 days after inclusion
measure: Rate of inotropic support
timeFrame: an average of 10 days after inclusion
measure: Number of hemodynamic instability requiring fluid expansion
timeFrame: an average of 10 days after inclusion
measure: Change in systolic blood
timeFrame: Hour 24
measure: Change in heart rate
timeFrame: Hour 24
measure: Urine output
timeFrame: Hour 24
measure: The duration of hospitalization in intensive care
timeFrame: an average of month 1
measure: Hospitalizations for cardiovascular reason one month after acute myocardial infarction
timeFrame: month 1
measure: One month mortality
timeFrame: month 1
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pascal Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: