Acute Myocardial Infarction With Right Ventricular ExtensionPhase 3FAMIENCT02905760
Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction
A Phase 3 study testing Furosemide and Vascular filling in people with Acute Myocardial Infarction With Right Ventricular Extension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction With Right Ventricular Extension
- What is being tested?
- Furosemide and Vascular filling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Jan 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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%
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction With Right Ventricular Extension: A Multicentric Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Furosemide, Placebo filling, Placebo furosemide, Vascular filling
- Keywords
- Acute Myocardial Infarction, Right ventricular infarction, Diuretic, Fluid Expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Also called Diuretics, LASILIX.
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)
Placebo fillingDrug
Also called G5
Placebo filling: Glucose 5%, 500mL infused over 30 minutes.
Placebo furosemideDrug
Also called G5
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).
Vascular fillingDrug
Also called Fluid expansion, Sodium Chloride NaCl 0.9%.
Vascular filling: Sodium 0.9% 500mL infused over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Furosemide | Experimental | Furosemide and Placebo filling (Glucose 5%). Receives: 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 Receives: Drug: Placebo furosemide; Drug: Vascular filling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Hour 24
Secondary outcomes (9)
Intra-hospital mortality
Measured: an average of 10 days after inclusion
Rate of inotropic support
Measured: an average of 10 days after inclusion
Number of hemodynamic instability requiring fluid expansion
Measured: an average of 10 days after inclusion
Change in systolic blood
Measured: Hour 24
Change in heart rate
Measured: Hour 24
Urine output
Measured: Hour 24
The duration of hospitalization in intensive care
Measured: an average of month 1
Hospitalizations for cardiovascular reason one month after acute myocardial infarction
Measured: month 1
One month mortality
Measured: month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction With Right Ventricular ExtensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Lim, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905760
- Sponsor's protocol ID
- P150801
- Acronym
- FAMIE
- Status last verified
- Jul 2016
- First submitted
- 31 Jul 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction With Right Ventricular Extension: A Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02905760
- Acronym / sponsor ID
- FAMIE / P150801
- Keywords
- Acute Myocardial Infarction, Right ventricular infarction, Diuretic, Fluid Expansion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide | Experimental | Drug: Furosemide, Drug: Placebo fillingFurosemide and Placebo filling (Glucose 5%). |
| Fluid expansion | Active comparator | Drug: Placebo furosemide, Drug: Vascular fillingPlacebo furosemide (Glucose 5%) and Vascular filling The vascular filling is the gold standard in the treatment of acute myocardial infarction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age >18 years
- Inferior acute myocardial infarction (≤J + 7)
- Right ventricular extension defined by one following echocardiographic criteria:
- Inferior vena cava dilatation (≥20mm) and non-compliant (changes <50%) associated with one hemodynamic instability criteria:
- Informed consent for study participation signed.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FurosemideAlso: Diuretics, LASILIX.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) | Drug | Furosemide |
| Placebo fillingAlso: G5Placebo filling: Glucose 5%, 500mL infused over 30 minutes. | Drug | Furosemide |
| Placebo furosemideAlso: G5Placebo furosemide: glucose 5% for injection reconditioned glass bottle like "penicillin" of 80mg/8mL. Injection by slow intravenous (1 to 2 minutes per 80mg vial). | Drug | Fluid expansion |
| Vascular fillingAlso: Fluid expansion, Sodium Chloride NaCl 0.9%.Vascular filling: Sodium 0.9% 500mL infused over 30 minutes. | Drug | Fluid expansion |
Primary outcome
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
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Lim, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide and Vascular filling in people with Acute Myocardial Infarction With Right Ventricular Extension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal Lim, MD, PhD ((0)1 49 81 45 84 ext. +33, lim.pascal.hmn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At Hour 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.