ESC heart failure · 2026
Colchicine in patients with chronic inflammatory cardiomyopathy: rationale and design of the CMP-MYTHiC.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Ammirati Enrico, Cartella Iside, Ciabatti Michele, Colombo Giada, Masetti Marco, Pieroni Maurizio, Gallone Guglielmo, Peretto Giovanni, Potena Luciano, Scacciavillani Roberto, Raineri Claudia, Caputo Adriano, Pedrotti Patrizia, Sormani Paola, Conti Nicolina, Merlo Marco, Imazio Massimo, Pani Arianna, Ciliberti Mirko L, Gentile Piero, Pontone Gianluca, Villatore Andrea, Pezzullo Enrica, Palazzini Matteo, Casella Michela, Valsecchi Maria Grazia, Burzotta Francesco, Carmina Veronica, Garascia Andrea, Scarale Antonio F, Bernasconi Davide P, Loffredo Francesco S, Narducci Maria Lucia
Аннотация
INTRODUCTION: Acute myocarditis can lead to chronic inflammatory cardiomyopathy (Infl-CMP), a condition characterized by increased risk of ventricular arrhythmias (VA), left ventricular (LV) systolic dysfunction (LVSD), and heart failure (HF). Immunosuppressive therapy is generally not recommended for Infl-CMP when diagnosed non-invasively by cardiac magnetic resonance imaging (CMRI) or fluorodeoxyglucose-positron emission tomography (FDG-PET). We are assessing, in the CMP-MYTHiC trial, whether colchicine (0.5 mg in patients <70 kg or 1 mg in patients ≥70 kg), an immunomodulatory drug with a good safety profile, can reduce myocardial inflammation in patients with Infl-CMP.
STUDY DESIGN: The CMP-MYTHiC, a multicenter investigator-initiated single-blinded randomized controlled trial, screens adult patients diagnosed with Infl-CMP by CMRI or FDG-PET within the prior 3 months at 12 Italian centres. Eligibility is further defined by the presence of VA or LVSD/HF phenotype. VA phenotype is determined by a high burden of premature ventricular complexes (PVCs) on baseline 24-h ECG ambulatory monitoring, non-sustained ventricular tachycardia (NSVT), or sustained ventricular tachycardia (SVT). The LVSD/HF phenotype is characterized by reduced LV ejection fraction (LVEF <50% on echocardiogram or <60% on CMRI) or elevated natriuretic peptide levels. Key exclusion criteria include a history of myocardial infarction, cardiomyopathy attributed to other specific causes, and systemic autoimmune disorders.The efficacy of colchicine compared with placebo will be assessed when CMRI or FDG-PET scans and 24-h ambulatory ECG monitoring are repeated at 6 months after randomization. The primary endpoint of the trial analysed according to the intention-to-treat population is the proportion of patients who are alive and free from any clinical (cardiac death or hospitalization due to HF or VA episodes), arrhythmic (PVC burden increase ≥50%, NSVT increase ≥30%, or any SVT), or imaging (LVEF reduction >10% or new areas of oedema plus increased inflammation) worsening, and who demonstrate improvement in either imaging (reduction in oedema on CMRI or FDG uptake) or arrhythmic (PVC burden reduction ≥70% with no NSVT/SVT) outcomes at 6 months. Assuming 80% power with an overall type I error of 0.025 using one-sided Fisher's Exact test, 40 patients per group are required to demonstrate that the primary endpoint will be reached in 66% of patients in the colchicine group compared with 33% in the placebo. Twenty-nine patients were randomized since December 2023, and the conclusion is expected in 2029.
DISCUSSION: The results can define the role of colchicine in treating patients with Infl-CMP non-invasively diagnosed by CMRI or FDG-PET.
CLINICALTRIALS.GOV IDENTIFIER: NCT06158698.
STUDY DESIGN: The CMP-MYTHiC, a multicenter investigator-initiated single-blinded randomized controlled trial, screens adult patients diagnosed with Infl-CMP by CMRI or FDG-PET within the prior 3 months at 12 Italian centres. Eligibility is further defined by the presence of VA or LVSD/HF phenotype. VA phenotype is determined by a high burden of premature ventricular complexes (PVCs) on baseline 24-h ECG ambulatory monitoring, non-sustained ventricular tachycardia (NSVT), or sustained ventricular tachycardia (SVT). The LVSD/HF phenotype is characterized by reduced LV ejection fraction (LVEF <50% on echocardiogram or <60% on CMRI) or elevated natriuretic peptide levels. Key exclusion criteria include a history of myocardial infarction, cardiomyopathy attributed to other specific causes, and systemic autoimmune disorders.The efficacy of colchicine compared with placebo will be assessed when CMRI or FDG-PET scans and 24-h ambulatory ECG monitoring are repeated at 6 months after randomization. The primary endpoint of the trial analysed according to the intention-to-treat population is the proportion of patients who are alive and free from any clinical (cardiac death or hospitalization due to HF or VA episodes), arrhythmic (PVC burden increase ≥50%, NSVT increase ≥30%, or any SVT), or imaging (LVEF reduction >10% or new areas of oedema plus increased inflammation) worsening, and who demonstrate improvement in either imaging (reduction in oedema on CMRI or FDG uptake) or arrhythmic (PVC burden reduction ≥70% with no NSVT/SVT) outcomes at 6 months. Assuming 80% power with an overall type I error of 0.025 using one-sided Fisher's Exact test, 40 patients per group are required to demonstrate that the primary endpoint will be reached in 66% of patients in the colchicine group compared with 33% in the placebo. Twenty-nine patients were randomized since December 2023, and the conclusion is expected in 2029.
DISCUSSION: The results can define the role of colchicine in treating patients with Infl-CMP non-invasively diagnosed by CMRI or FDG-PET.
CLINICALTRIALS.GOV IDENTIFIER: NCT06158698.