Acute MyocarditisPhase 3COTAMNCT06522100
Corticoid Therapy in Acute Myocarditis
A Phase 3 study testing Intravenous administration of Methylprednisolone and Oral Prednisone in people with Acute Myocarditis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Refer to the "Detailed Description" section. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocarditis
- What is being tested?
- Intravenous administration of Methylprednisolone and Oral Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 16 Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Written signed informed consent
- Affiliation to the French health care system or to another social protection scheme with the exception of State Medical Aid
- Active myocarditis defined by (all items are required):
- Acute chest pain and/or unexplained heart failure and/or syncope and/or sustained ventricular arrhythmias and/or aborted sudden death and/or cardiogenic shock and/or ECG modification (atrioventricular block or bundle branch block or sinus arrest or ST or T waves change or ventricular arrhythmia or atrial fibrillation or abnormal Q waves)
- And troponin rise (1,5 times the normal range)
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- And diagnosis of active myocarditis on Cardiac Magnetic Resonance (according to Lake-Louise criteria) or by histological evidence on endomyocardial biopsy (Dallas's criteria)
- Left-ventricular dysfunction defined as LVEF < 50% and/or GLS < -16% assessed with 2D-TTE
- Normal coronary angiography or CT Scan (without stenosis > 50%) during the previous year
Who cannot join
- Active coronary disease
- Other causes of chronic heart failure (coronary artery disease, primary valvular heart disease, congenital heart disease)
- Other etiology of myocarditis requiring corticosteroids treatment as giant cells myocarditis, eosinophilic myocarditis and cardiac sarcoidosis or immune checkpoint inhibitor myocarditis
- Other auto-immune or inflammatory disease requiring corticosteroids treatment within 6 months before enrolment
- Pregnancy or breastfeeding
- Woman of childbearing potential without effective method of birth control (included contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices)
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- Patient deprived of liberty or under Curatorship/Tutorship, safeguard of justice, according to French law
- Foreseeable inability, according to the investigator, to participate in all the visits, treatments and measures provided for in the protocol
- Patient not speaking or understanding French
- Concomitant participation in another clinical trial on medical product for human use, to a clinical investigation on a medical device, to interventional study involving human participants or in the exclusion period at the end of a previous clinical trial on medical product for human use, a clinical investigation on a medical device, or study involving human participants. Participation in non-interventional research is permitted.
- Any medical and/or cognitive condition which limits the ability of participant to participate in study
- Contra-indication linked to steroids (Methylprednisolone and Prednisone) according to summary of product characteristics:
- Any infectious condition excluding the specified therapeutic indications of Methylprednisolone and Prednisone
- Certain evolving viruses (notably hepatitis, herpes, chickenpox, shingles)
- Psychotic states not yet controlled by treatment
- Recent live vaccines or live attenuated vaccines in patients receiving dosages greater than 20 mg/day of prednisone equivalent for more than two weeks and during the 3 months following the cessation of corticosteroid therapy (risk of generalized vaccine disease possibly fatal)
- Hypersensitivity to the active substances or to any of the excipients
- Contra-indication linked to auxiliary drugs according to respective summary of product characteristics:
- Beta-blockade
- Angiotensin-converting-enzyme inhibitor (ACE-I)
- Angiotensin receptor blockers (ARB)
- Mineralocorticoid antagonists (MRA)
- Angiotensin receptor-neprilysin inhibitor (ARNi)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Use of Glucocorticoids Therapy in Acute Myocarditis With Severe Left Ventricular Dysfunction: a Multicenter Randomized Controlled Trial
Refer to the "Detailed Description" section.
Read the detailed description
Introduction: Acute myocarditis (AM) is an inflammatory disease of the heart. The incidence is approximately 22 out of 100 000 patients annually. Clinically, it ranges from subclinical pauci-symptomatic forms to life-threatening arrhythmias, cardiogenic shock and sudden cardiac death. In approximately more than 70% of cases, AM resolves spontaneously. In the remaining patients, it evolves to a poor prognosis with left ventricular dilatation, reduced cardiac contractility and progression to chronic heart failure.
Complicated AM is defined as an AM with Left Ventricular Ejection Fraction (LVEF) < 50% and/or a sustained ventricular arrhythmia and/or a hemodynamic instability. Complicated AM is often associated with a poor prognosis (in example risk of heart transplantation of 10.4% at 30 days and 14.7% at 5-year follow up) whereas uncomplicated AM have none.
Administration of immunosuppressive treatment (IT) is still debated. According to experts' consensus, immunosuppressive treatment should be considered in complicated AM and should be used in recommended in case of fulminant myocarditis (acute myocarditis with a presentation of cardiogenic shock, ventricular arrhythmias, or multiorgan system failure). Nevertheless, there is no data on use of glucocorticoids (GC) in complicated AM.
Early application of high dose of GC in AM can control the cytokine storm and the inflammatory response, rather than suppressing the overall immune response. Best timing for their administration remains unknown. The aim of this multicenter controlled randomized study is to demonstrate the benefit of high dose of GC therapy on mortality and cardiac events in patients with AM and left ventricular (LV) dysfunction.
Hypothesis/Objective: The main objective is to evaluate in patients with acute myocarditis with left-ventricular dysfunction the efficacy of a pulse of Methylprednisolone IV for 3 days at diagnosis followed by Prednisone per os versus placebo IV followed by placebo per os in association with conventional Heart Failure (HF) therapy on the occurrence of Major Cardiovascular Events (MACE) and/or persistence of left ventricular dysfunction defined as LVEF < 50% and/or Global Longitudinal Strain (GLS) < -16% between baseline and at 6 months.
The primary endpoint is the Major Cardiovascular Events (MACE) and/or persistence of left ventricular dysfunction defined as LVEF < 50% and/or Global Longitudinal Strain (GLS) < - 16% between baseline (D-2) and 6 months (M6) follow up. MACE is a combined criterion that includes all-cause mortality, heart failure hospitalization, sustained ventricular arrhythmia, heart transplantation or assistance and recurrent acute myocarditis with LV dysfunction at 6 months.
Method: Phase III, prospective, randomized, placebo controlled, superiority, double blinded trial with 2 parallel groups randomized in a 1:1 ratio:
- Experimental group: Methylprednisolone IV for 3 days followed by Prednisone per os + conventional HF treatment.
- Control group: placebo of Methylprednisolone IV followed by placebo of Prednisone per os + conventional HF treatment.
- Conditions
- Acute Myocarditis
- Being tested
- Intravenous administration of Methylprednisolone, Oral Prednisone, Perfusion of placebo, Oral Prednisone placebo
- Keywords
- Acute myocarditis, Corticoids, Left ventricular dysfunction
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous administration of MethylprednisoloneDrug
Patients will take intravenous administration of Methylprednisolone (500mg/100ml by IV over 30 minutes per day) for 3 days.
Oral PrednisoneDrug
After intravenous administration of Methylprednisolone patients will take by oral Prednisone 1mg/kg per day once a day (with a maximum dose of 90 mg per day for patients weighing > 90kg) for 1 month, followed with a progressive decrease of 10 mg Prednisone every 15 days until a dose of 10mg per day during 15 days (= stop).
Perfusion of placeboDrug
Patients will take perfusion of placebo (G5%: 100ml over 30 minutes per day) for 3 days.
Oral Prednisone placeboDrug
After the perfusion of placebo, patients will take by oral Prednisone placebo once a day for the same duration as that required if the patient was in the investigational medicinal products group (1 month + progressive decrease).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Randomization in experimental group in addition to conventional HF therapy for 6 months. Receives: Drug: Intravenous administration of Methylprednisolone; Drug: Oral Prednisone |
| Control group | Placebo comparator | Randomization in control group in addition to conventional HF therapy for 6 months. Receives: Drug: Perfusion of placebo; Drug: Oral Prednisone placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatments
Major Cardiovascular Events (MACE) and/or persistence of left ventricular dysfunction defined as LVEF < 50% and/or Global Longitudinal Strain (GLS) < - 16%. MACE is a combined criterion that includes all-cause mortality, heart failure hospitalization, sustained ventricular arrhythmia, heart transplantation or assistance and recurrent acute myocarditis with LV dysfunction.
Measured: 6 months
Secondary outcomes (11)
Changes in LVEF ≥ 50%
Changes in LVEF ≥ 50% at 6 months using 2D trans-thoracic echocardiography (2D-TTE)
Measured: 6 months
Global Longitudinal Strain (GLS) ≥ -16%
Changes in Global Longitudinal Strain (GLS) ≥ -16% at 6 months using 2D-TTE
Measured: 6 months
All-cause mortality
Occurred of a death
Measured: 6 months
Heart failure hospitalization
Occurred of hospitalization for heart failure
Measured: 6 months
Sustained ventricular arrhythmia
Occurred of sustained ventricular arrhythmia
Measured: 6 months
Heart transplantation
Occurred of heart transplantation
Measured: 6 months
Heart assistance by extracorporeal membrane oxygenation (ECMO), Intra-aortic balloon pump (IABP), Impella® device or Left Ventricular Assistance Devices (LVAD)
Need for heart assistance by extracorporeal membrane oxygenation (ECMO), Intra-aortic balloon pump (IABP), Impella® device or Left Ventricular Assistance Devices (LVAD)
Measured: 6 months
Recurrence of acute myocarditis with LV dysfunction
Time to recurrence of acute myocarditis with LV dysfunction
Measured: 6 months
Safety of the treatment regimens
Adverse events and serious adverse events
Measured: 6 months
Adherence to the treatment regimen
Compliance to the treatment (premature ending of the treatment or proportion of non-administered doses of the treatment)
Measured: 6 months
Evaluate quality of life using Minnesota living with heart failure questionnaire (MLHFQ)
Increased quality of life evaluated by Minnesota living with heart failure questionnaire during follow up. 21 questions rated from 0 to 5. Overall score from 0 to 105. The score increase with the adverse impact of heart failure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Feb 2025 (estimated)
- Primary completion16 Aug 2028 (estimated)
- Study completion16 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MyocarditisStudies 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
- Model description
- Phase III, prospective, randomized, placebo controlled, superiority, double blinded trial with 2 parallel groups randomized in a 1:1 ratio. Patients will be hospitalized in Cardiology or Intensive Care Unit for a suspicion of an acute myocarditis. They will have an 2D-TTE to confirm a left ventricular dysfunction (LVEF \< 50% and/or Global longitudinal strain \[GLS\] \< -16%) and a cardiac magnetic resonance imaging or an endomyocardial biopsy will be performed to prove acute myocarditis. Coronary artery disease will be excluded by coronary angiography or Cardiac CT Scan. Once diagnosis of complicated AM with left ventricular dysfunction done, investigators will have 48 hours to include the patients and randomize them. They will benefit of placebo or experimental treatment in addition of conventional treatment for 6 months. At M6, end of participation for each patients, they will benefit of cardiologist consultation with TTE and cardiac magnetic resonance imaging.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522100
- Sponsor's protocol ID
- APHP230855
- Acronym
- COTAM
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Datas are own by assistance publique - hopitaux de paris, please contact sponsor for further information.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Glucocorticoids Therapy in Acute Myocarditis With Severe Left Ventricular Dysfunction: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06522100
- Acronym / sponsor ID
- COTAM / APHP230855
- Conditions
- Acute Myocarditis
- Keywords
- Acute myocarditis, Corticoids, Left ventricular dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 16 Aug 2028 (estimated)
- Study completion
- 16 Aug 2028 (estimated)
- First posted
- 26 Jul 2024 (actual)
- 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.
Refer to the "Detailed Description" section.
Detailed description
Introduction: Acute myocarditis (AM) is an inflammatory disease of the heart. The incidence is approximately 22 out of 100 000 patients annually. Clinically, it ranges from subclinical pauci-symptomatic forms to life-threatening arrhythmias, cardiogenic shock and sudden cardiac death. In approximately more than 70% of cases, AM resolves spontaneously. In the remaining patients, it evolves to a poor prognosis with left ventricular dilatation, reduced cardiac contractility and progression to chronic heart failure.
Complicated AM is defined as an AM with Left Ventricular Ejection Fraction (LVEF) < 50% and/or a sustained ventricular arrhythmia and/or a hemodynamic instability. Complicated AM is often associated with a poor prognosis (in example risk of heart transplantation of 10.4% at 30 days and 14.7% at 5-year follow up) whereas uncomplicated AM have none.
Administration of immunosuppressive treatment (IT) is still debated. According to experts' consensus, immunosuppressive treatment should be considered in complicated AM and should be used in recommended in case of fulminant myocarditis (acute myocarditis with a presentation of cardiogenic shock, ventricular arrhythmias, or multiorgan system failure). Nevertheless, there is no data on use of glucocorticoids (GC) in complicated AM.
Early application of high dose of GC in AM can control the cytokine storm and the inflammatory response, rather than suppressing the overall immune response. Best timing for their administration remains unknown. The aim of this multicenter controlled randomized study is to demonstrate the benefit of high dose of GC therapy on mortality and cardiac events in patients with AM and left ventricular (LV) dysfunction.
Hypothesis/Objective: The main objective is to evaluate in patients with acute myocarditis with left-ventricular dysfunction the efficacy of a pulse of Methylprednisolone IV for 3 days at diagnosis followed by Prednisone per os versus placebo IV followed by placebo per os in association with conventional Heart Failure (HF) therapy on the occurrence of Major Cardiovascular Events (MACE) and/or persistence of left ventricular dysfunction defined as LVEF < 50% and/or Global Longitudinal Strain (GLS) < -16% between baseline and at 6 months.
The primary endpoint is the Major Cardiovascular Events (MACE) and/or persistence of left ventricular dysfunction defined as LVEF < 50% and/or Global Longitudinal Strain (GLS) < - 16% between baseline (D-2) and 6 months (M6) follow up. MACE is a combined criterion that includes all-cause mortality, heart failure hospitalization, sustained ventricular arrhythmia, heart transplantation or assistance and recurrent acute myocarditis with LV dysfunction at 6 months.
Method: Phase III, prospective, randomized, placebo controlled, superiority, double blinded trial with 2 parallel groups randomized in a 1:1 ratio:
- Experimental group: Methylprednisolone IV for 3 days followed by Prednisone per os + conventional HF treatment.
- Control group: placebo of Methylprednisolone IV followed by placebo of Prednisone per os + conventional HF treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase III, prospective, randomized, placebo controlled, superiority, double blinded trial with 2 parallel groups randomized in a 1:1 ratio. Patients will be hospitalized in Cardiology or Intensive Care Unit for a suspicion of an acute myocarditis. They will have an 2D-TTE to confirm a left ventricular dysfunction (LVEF < 50% and/or Global longitudinal strain [GLS] < -16%) and a cardiac magnetic resonance imaging or an endomyocardial biopsy will be performed to prove acute myocarditis. Coronary artery disease will be excluded by coronary angiography or Cardiac CT Scan. Once diagnosis of complicated AM with left ventricular dysfunction done, investigators will have 48 hours to include the patients and randomize them. They will benefit of placebo or experimental treatment in addition of conventional treatment for 6 months. At M6, end of participation for each patients, they will benefit of cardiologist consultation with TTE and cardiac magnetic resonance imaging.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Intravenous administration of Methylprednisolone, Drug: Oral PrednisoneRandomization in experimental group in addition to conventional HF therapy for 6 months. |
| Control group | Placebo comparator | Drug: Perfusion of placebo, Drug: Oral Prednisone placeboRandomization in control group in addition to conventional HF therapy for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Written signed informed consent
- Affiliation to the French health care system or to another social protection scheme with the exception of State Medical Aid
- Active myocarditis defined by (all items are required):
- Left-ventricular dysfunction defined as LVEF < 50% and/or GLS < -16% assessed with 2D-TTE
Key exclusion criteria (23 listed)
- Active coronary disease
- Other causes of chronic heart failure (coronary artery disease, primary valvular heart disease, congenital heart disease)
- Other etiology of myocarditis requiring corticosteroids treatment as giant cells myocarditis, eosinophilic myocarditis and cardiac sarcoidosis or immune checkpoint inhibitor myocarditis
- Other auto-immune or inflammatory disease requiring corticosteroids treatment within 6 months before enrolment
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Intravenous administration of MethylprednisolonePatients will take intravenous administration of Methylprednisolone (500mg/100ml by IV over 30 minutes per day) for 3 days. | Drug | Experimental group |
| Oral PrednisoneAfter intravenous administration of Methylprednisolone patients will take by oral Prednisone 1mg/kg per day once a day (with a maximum dose of 90 mg per day for patients weighing > 90kg) for 1 month, followed with a progressive decrease of 10 mg Prednisone every 15 days until a dose of 10mg per day during 15 days (= stop). | Drug | Experimental group |
| Perfusion of placeboPatients will take perfusion of placebo (G5%: 100ml over 30 minutes per day) for 3 days. | Drug | Control group |
| Oral Prednisone placeboAfter the perfusion of placebo, patients will take by oral Prednisone placebo once a day for the same duration as that required if the patient was in the investigational medicinal products group (1 month + progressive decrease). | Drug | Control group |
Primary outcome
Efficacy of treatments
Time frame: 6 months
Major Cardiovascular Events (MACE) and/or persistence of left ventricular dysfunction defined as LVEF < 50% and/or Global Longitudinal Strain (GLS) < - 16%. MACE is a combined criterion that includes all-cause mortality, heart failure hospitalization, sustained ventricular arrhythmia, heart transplantation or assistance and recurrent acute myocarditis with LV dysfunction.
11 secondary outcomes
Changes in LVEF ≥ 50%
Time frame: 6 months
Global Longitudinal Strain (GLS) ≥ -16%
Time frame: 6 months
All-cause mortality
Time frame: 6 months
Heart failure hospitalization
Time frame: 6 months
Sustained ventricular arrhythmia
Time frame: 6 months
Heart transplantation
Time frame: 6 months
Heart assistance by extracorporeal membrane oxygenation (ECMO), Intra-aortic balloon pump (IABP), Impella® device or Left Ventricular Assistance Devices (LVAD)
Time frame: 6 months
Recurrence of acute myocarditis with LV dysfunction
Time frame: 6 months
Safety of the treatment regimens
Time frame: 6 months
Adherence to the treatment regimen
Time frame: 6 months
Evaluate quality of life using Minnesota living with heart failure questionnaire (MLHFQ)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No. Datas are own by assistance publique - hopitaux de paris, please contact sponsor for further information.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous administration of Methylprednisolone and Oral Prednisone in people with Acute Myocarditis, run by Assistance Publique - Hôpitaux de Paris.
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 9 inclusion and 23 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: opening soon, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David AOUATE, Dr (+33 1 49 81 45 84, davidrobin.aouate@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of treatments (time frame: 6 months). 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 29 Jul 2024.