NCT03018834

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2017

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

4.1 years

First QC Date

December 12, 2016

Last Update Submit

March 5, 2024

Conditions

Acute Myocarditis

Keywords

Acute MyocarditisANAKINRA

Outcome Measures

Primary Outcomes (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

    within 28 days post hospitalization

Secondary Outcomes (14)

  • Total cost

    on average 14 days

  • Total Quality Adjusted Life Year (QALYs),

    on average 14 days

  • Incremental cost effectiveness

    on average 14 days

  • Cost utility ratios

    on average 14 days

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

    at 6 month

  • +9 more secondary outcomes

Study Arms (2)

A: ANAKINRA

EXPERIMENTAL

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.

Drug: ANAKINRA 100 mg/daily subcutaneously

B: Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

ANAKINRA 100 mg/daily subcutaneouslyDRUG

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.

Also known as: Kineret
A: ANAKINRA
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.

B: Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Paris, 75013, France

Location

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

Paris, 75013, France

Location

Related Publications (2)

  • 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.

    PMID: 39705605DERIVED

  • 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.

    PMID: 37640625DERIVED

MeSH Terms

Interventions

Interleukin 1 Receptor Antagonist Protein

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Mathieu KERNEIS, MD

    ACTION Study Group - Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Fleur COHEN AUBART, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Gilles MONTALESCOT, MD, PhD

    ACTION Study Group - Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2016

First Posted

January 12, 2017

Study Start

May 30, 2017

Primary Completion

June 28, 2021

Study Completion

May 30, 2022

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

FR(2)