None listed
Conditions
Interventions
Trade Name: COLCHICINE OPOCALCIUM 1 mg, comprimé sécable
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Assistance Publique – Hôpitaux de Paris (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years and 99 percentile of reference value, • Myocarditis diagnostic confirmation (by CMR, according to the Lake Louise criteria with the presence of myocardial damage, • No evidence for ischemic heart disease on coronary angiography or coronary computed tomography angiography for patients with age > 40-year-old with one or more cardiovascular risk factor (hypertension, smoking, hypercholesterolemia, diabetes, personal or family history of coronary artery disease), • Woman of child-bearing age with an effective contraception method according to the investigator for the duration of treatment and 1 month after, • Man accepting effective contraception for the duration of treatment and 1 month after, • Patients with affiliation to the French Health Care System “sécurité sociale”, • Written informed consent of the patient obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: NA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study will be to assess in patients presenting with acute myocarditis the efficacy of a 6 months treatment with colchicine versus placebo on the inflammatory myocardial damage evaluated by Late Gadolinium Enhancement (LGE) (% of LV mass) on CMR or on clinical outcome assessed on the rate of rehospitalization for heart Failure or acute myocarditis recurrence; or clinically relevant recurrent chest pain (defined as leading to an unplanned/urgent consultation or hospitalization); or sustained ventricular arrhythmias; or left ventricular assistance; or heart transplantation; or cardiovascular death at 6 months. ;Secondary Objective: 1.To evaluate the safety of colchicine in acute myocarditis during 6 months: 2.To evaluate the efficacy of colchicine on secondary efficacy endpoints, including: a/ Each component of the composite clinical endpoint at 6 months and one year: -Occurrence of heart failure or acute myocarditis recurrence; -Occurrence of clinically relevant recurrent chest pain (defined as leading to an unplanned/urgent consultation or hospitalization) -Occurrence of sustained ventricular arrhythmias, -Occurrence of left ventricular assistance -Occurrence of heart transplantation, -Occurrence of cardiovascular death b/ The LVEF, LV end-diastolic and end-systolic volumes, determined by a follow-up CMR at 6 months determined centrally by the Corelab, c/ The relative variation in LVEF, LV end-diastolic and end-systolic volumes, determined by a follow-up transthoracic echocardiography at 6 months .... ;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Le pourcentage de changement de l’osmolalité urinaire entre baseline (avant le traitement) et à 6 et 12 mois. 2. Nombre moyen de mictions nocturnes déclaré par le patient avant le traitement et à 2, 6 et 12 mois. 3. Score des échelles d'intensité de la soif et de détresse avant le traitement et à 2, 6 et 12 mois. 4. Présence d'une polyurie (définie comme un débit urinaire quotidien > 3 L/jour) après 2, 6 et 12 mois de traitement. 5. Score de l'échelle de qualité de vie (SF36) avant le traitement et à 2, 6 et 12 mois. 6. eDFG (estimé par l'équation CKD-EPI basée sur la mesure de la créatinine sérique standardisée) avant le traitement et à 2, 6 et 12 mois. 7.a Scores de l'échelle d'humeur (YMRS et MADRS), score de l'échelle d'anxiété (GAD7) et score du sommeil de Pittsburgh (PSQI) avant le traitement et à 2, 6 et 12 mois. 7.b Nombre total d'admissions à l'hôpital pour rechute maniaque ou dépressive pendant les 12 mois de traitement. 8. Différence des niveaux résiduels de lithium plasmatique avant et après la période de traitement de 2 mois.;Timepoint(s) of evaluation of this end point: - CMR at 6 months - Composite clinical endpoint at 6 months and 1 year | — |
Countries
France
Contacts
Public ContactSEYMOUR-INAMO
APHP
Outcome results
None listed