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

NCT02905760 | Unknown Phase 3 DMC

• 1 other identifier: P150801
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction With Right Ventricular Extension

Keywords

Acute Myocardial Infarction; Right ventricular infarction; Diuretic; Fluid Expansion

Outcome Measures

Primary Outcomes (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.

  At Hour 24

Secondary Outcomes (9)

• Intra-hospital mortality

  an average of 10 days after inclusion

• Rate of inotropic support

  an average of 10 days after inclusion

• Number of hemodynamic instability requiring fluid expansion

  an average of 10 days after inclusion

• Change in systolic blood

  Hour 24

• Change in heart rate

  Hour 24

Study Arms (2)

Furosemide

EXPERIMENTAL

Furosemide and Placebo filling (Glucose 5%).

Drug: Furosemide; Drug: Placebo filling

Fluid expansion

ACTIVE COMPARATOR

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

Drug: Placebo furosemide; Drug: Vascular filling

Interventions

Furosemide DRUG

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)

Also known as: Diuretics, LASILIX.

Furosemide

Placebo filling DRUG

Placebo filling: Glucose 5%, 500mL infused over 30 minutes.

Also known as: G5

Furosemide

Placebo furosemide DRUG

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).

Also known as: G5

Fluid expansion

Vascular filling DRUG

Vascular filling: Sodium 0.9% 500mL infused over 30 minutes.

Also known as: Fluid expansion, Sodium Chloride NaCl 0.9%.

Fluid expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

MeSH Terms

Interventions

Furosemide; Diuretics

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Pascal Lim, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Lim, MD, PhD

CONTACT

(0)1 49 81 45 84; lim.pascal.hmn@gmail.com

Ludivine Brouard, CRA

CONTACT

(0)1 49 81 37 53; ludivine.brouard@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2016
• First Posted: September 19, 2016
• Study Start: December 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: January 1, 2019
• Last Updated: September 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)