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Acute MyocarditisPhase 2/3ARAMISNCT03018834

Anakinra Versus Placebo for the Treatment of Acute MyocarditIS

A Phase 2/3 study testing ANAKINRA 100 mg/daily subcutaneously in people with Acute Myocarditis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is no specific treatment of acute myocarditis, especially during the inflammatory period. Interleukin (IL) is specifically involved during this period and play a role in myocardial oedema. ANAKINRA, an IL-1β Blocker, is a new treatment that has never been evaluated in myocarditis. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Acute Myocarditis
What is being tested?
ANAKINRA 100 mg/daily subcutaneously
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
2 sitesFrance
Study dates
30 May 2017to 30 May 2022
Phase
Phase 2/3
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 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients hospitalized for Acute myocarditis defined as:
  • Chest Pain (or modification of the ECG) AND Troponin Rise (*1.5 Normal range) AND Myocarditis proven by MRI in the first 72h after admission
  • Age > 18 and <65 years old
  • Accepting effective contraception during treatment duration (men and women childbearing potential)
  • Signed informed consent Normal Coronary angiography or coronary CT Scan (made during the previous year is acceptable) (normal is defined as stenosis < 50%) (In the case of patients under 40 with typical MRI of myocarditis, coronary angiography is not mandatory and left to the doctor's discretion)

Who cannot join

  • Active coronary disease
  • Clinical Suspicion or proven underlying disease: systemic lupus, antiphospholipid antibodies, Lyme disease, trypanosomiase disease, myositis, signs of sarcoidosis, giant cell myocarditis, treated chronic inflammatory disease, tuberculosis, HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV), Hepatitis B virus (HBV) infection,
  • Latex allergy
  • Pregnancy, breastfeeding
  • Contra-indication to ANAKINRA (known hypersensitivity to the active substance or to any of the excipients, neutropenia < 1,5.10^9/L)
  • Renal failure, Creatine Clearance (CrCl) < 30 ml/min (MDRD)
Show all 14Show fewer
  • Malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study
  • History of malignancy
  • Non Steroidian Anti Inflammatory drug within the past 14 days
  • Anti Tumor Necrosis Factor (TNF) within the past 14 days
  • No affiliation to the French Health Care System "sécurité sociale"
  • Hepatic impairment = Child-Pugh Class C
  • Mechanical ventilation
  • Circulatory assistance

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • ACTION Study Group - Department of Cardiology - Pitié Salpétrière Hospital, 47 Bd de l'Hopital

    Paris, 75013

  • Department of internal medicine - Pitié Salpétrière Hospital, 47 Bd de l'Hopital

    Paris, 75013

Other trials in France

About this study

Official title: Anakinra Versus Placebo Double Blind Randomized Controlled Trial for the Treatment of Acute MyocarditIS

There is no specific treatment of acute myocarditis, especially during the inflammatory period. Interleukin (IL) is specifically involved during this period and play a role in myocardial oedema. ANAKINRA, an IL-1β Blocker, is a new treatment that has never been evaluated in myocarditis. The benefit for the patient could be important with a reduction of heart failure and ventricular arrhythmias.

Hypothesis : ANAKINRA in addition to standard therapy for treatment of Acute Myocarditis is superior to standard therapy based on an association of beta-blockers and Angiotensin-Converting-Enzyme inhibitor (ACE).

Read the detailed description

It is a Double Blind Randomized clinical trial Phase IIb of superiority, enrolling two groups: one group treated with the standard of care, defined as the maximum tolerated dosage of any beta blockers and ACE, and placebo versus ANAKINRA in addition to the standard of care in patients treated for an acute Myocarditis.

Patients will be randomized to receive ANAKINRA 100 mg/daily or placebo subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months. Randomization 1:1 will be conducted centrally using the electronic Case Report Form (eCRF).

As an exploratory analysis, a second randomization for ACE discontinuation in patients without left ventricular dysfunction (LVEF > 50%) at one month post discharge will be performed.

One group will stopped the treatment at one month and the second group will continued the ACE for 6 months. This second randomization is in open label.

Being tested
ANAKINRA 100 mg/daily subcutaneously, Placebo
Keywords
Acute Myocarditis, ANAKINRA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANAKINRA 100 mg/daily subcutaneouslyDrug

    Also called Kineret

    ANAKINRA 100 mg/daily subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months.

  • PlaceboDrug

    PLACEBO 100 mg/daily subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months.

Study groups in NCT03018834
Study groupRoleWhat they receive
A: ANAKINRAExperimentalANAKINRA 100 mg/daily subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months.
Receives: Drug: ANAKINRA 100 mg/daily subcutaneously
B: PlaceboPlacebo comparatorPLACEBO 100 mg/daily subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of days alive free of any myocarditis complications

    Number of days alive free of any myocarditis complications defined as ventricular arrhythmias, heart failure, chest pain, ventricular dysfunction defined as LVEF<50%, within 28 days post hospitalization

    Measured: within 28 days post hospitalization

Secondary outcomes (14)

  1. Total cost

    Total cost

    Measured: on average 14 days

  2. Total Quality Adjusted Life Year (QALYs),

    measure of the perceived utility by patients of a medication (Anakinra) that corresponds to a year of life gained

    Measured: on average 14 days

  3. Incremental cost effectiveness

    cost-effectiveness of ANAKINRA in the setting of acute myocarditis

    Measured: on average 14 days

  4. Cost utility ratios

    Cost utility ratios

    Measured: on average 14 days

  5. Left Ventricul Ejection Fraction (LVEF) assessed by cardiac Magnetic Resonance Imaging (MRI)

    Left Ventricul Ejection Fraction (LVEF) assessed by cardiac Magnetic Resonance Imaging (MRI)

    Measured: at 6 month

  6. Left Ventricul Ejection Fraction (LVEF) assessed by Trans Thoracic Echocardiograhy (TTE)

    Left Ventricul Ejection Fraction (LVEF) assessed by Trans Thoracic Echocardiograhy (TTE)

    Measured: at 6 month

  7. LVEF assessed by cardiac MRI

    LVEF assessed by cardiac MRI

    Measured: at 1 year

  8. LVEF assessed by cardiac TTE

    LVEF assessed by cardiac TTE

    Measured: at 1 year

  9. All cause of death rate

    All cause of death rate

    Measured: during the 12 months follow-up

  10. Cardiovascular death

    Cardiovascular death

    Measured: at 12 months

  11. Heart Failure

    Heart Failure

    Measured: at 12 months

  12. Ventricular tachycardia

    Ventricular tachycardia

    Measured: during the 12 months follow-up

  13. NT-proBNP above 450 pg/mL (in patients aged below 50); above 900 pg/mL (age 50-75 years) or BNP ≤ 400pg/mL 50% decrease of the troponin level at discharge compared to admission

    NT-proBNP above 450 pg/mL (in patients aged below 50); above 900 pg/mL (age 50-75 years) or BNP ≤ 400pg/mL 50% decrease of the troponin level at discharge compared to admission

    Measured: at Day0

  14. NT-proBNP above 450 pg/mL (in patients aged below 50); above 900 pg/mL (age 50-75 years) or BNP ≤ 400pg/mL 50% decrease of the troponin level at discharge compared to admission

    NT-proBNP above 450 pg/mL (in patients aged below 50); above 900 pg/mL (age 50-75 years) or BNP ≤ 400pg/mL

    Measured: an average of 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2017 (estimated)
  2. Study start30 May 2017
  3. Primary completion28 Jun 2021
  4. Study completion30 May 2022

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03018834
Sponsor's protocol ID
P150921
Other IDs
2016-003433-20, 2016
Acronym
ARAMIS
Status last verified
Mar 2024
First submitted
12 Dec 2016
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Werner B, Roznowska-Wojtowicz A, Puchalski M. Diagnosis and Management of Pediatric Myocarditis. Pediatr Infect Dis J. 2025 Mar 1;44(3):e95-e98. doi: 10.1097/INF.0000000000004678. Epub 2024 Dec 17. No abstract available.

    PubMed 39705605

  • Kerneis M, Cohen F, Combes A, Amoura Z, Pare C, Brugier D, Puymirat E, Abtan J, Lattuca B, Dillinger JG, Hauguel-Moreau M, Silvain J, Salem JE, Gandjbakhch E, Hekimian G, Redheuil A, Vicaut E, Montalescot G; ACTION Study Group. Rationale and design of the ARAMIS trial: Anakinra versus placebo, a double blind randomized controlled trial for the treatment of acute myocarditis. Arch Cardiovasc Dis. 2023 Oct;116(10):460-466. doi: 10.1016/j.acvd.2023.07.004. Epub 2023 Aug 12.

    PubMed 37640625

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ANAKINRA 100 mg/daily subcutaneously in people with Acute Myocarditis, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of days alive free of any myocarditis complications (time frame: within 28 days post hospitalization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03018834, which also lists 2 linked publications.

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 6 Mar 2024.

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