Key result
Hydroxychloroquine plus prednisolone cuts major cardiovascular events ~72% vs. prednisolone alone in chronic inflammatory cardiomyopathy.
Why the study?
Chronic inflammatory cardiomyopathy is a long-term sequela of acute myocarditis, especially fulminant myocarditis, and hydroxychloroquine may benefit patients by inhibiting excessive inflammation.
Does hydroxychloroquine combined with prednisolone reduce adverse cardiovascular outcomes and improve heart function in patients with chronic inflammatory cardiomyopathy after fulminant myocarditis?
Does hydroxychloroquine combined with prednisolone reduce adverse cardiovascular outcomes and improve heart function in patients with chronic inflammatory cardiomyopathy after fulminant myocarditis?
Adding hydroxychloroquine to prednisolone for 12 months significantly reduces cardiovascular events and improves cardiac function in patients with chronic inflammatory cardiomyopathy following fulminant myocarditis.
May support adding hydroxychloroquine to prednisolone; provides first RCT evidence in this rare post-myocarditis population.
Background Chronic inflammatory cardiomyopathy (infl-CMP) is a long-term sequela caused by the chronicity of acute myocarditis, especially fulminant myocarditis (FM). Hydroxychloroquine (HCQ) may benefit these patients by inhibiting the excessive inflammatory response. Objectives To evaluated the efficacy and safety of HCQ in patients with chronic infl-CMP after FM. Methods In this multicenter, randomized trial, we evaluated the efficacy and safety of HCQ in patients with chronic infl-CMP after FM. The primary outcome of the trial was a composite of the cardiovascular outcomes time to cardiovascular death or heart transplant, hospitalization for heart failure or recurrence of myocarditis, permanent pacemaker, or implantable cardioverter defibrillator implantation. Secondary outcomes were changes in left ventricular ejection fraction (LVEF), left ventricular internal diastolic diameter (LVIDd), plasma levels of high-sensitivity cardiac Troponin I (hs-cTnI), N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity C-reactive protein (hs-CRP), and erythrocyte sedimentation rate (ESR) from baseline to 12 months. Results Fifty patients were randomized to receive HCQ combined with prednisolone (PDN) or PDN monotherapy for 12 months. Compared to PDN monotherapy, HCQ combined with PDN therapy reduced the primary composite outcome [hazard ratio (HR) = 0.28, 95% confidence interval (CI) = 0.11–0.71], and had significant changes in the increase of LVEF and the decrease of LVIDd, hs-cTnI, NT-proBNP and hs-CRP in patients with infl-CMP. No serious drug-related adverse events were recorded in either group. Furthermore, HCQ combined with PDN significantly reduced the levels of 16 plasma cytokines to normal levels. Conclusions 12 months of HCQ combined with PDN therapy significantly improved the prognosis and heart function, inhibited inflammation, and had acceptable safety in patients with infl-CMP after FM. These findings warrant larger clinical trials.
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He et al. (2025) studied this question. Hydroxychloroquine plus prednisolone reduced primary cardiovascular events by 72% (HR=0.28) and improved heart function and inflammation in chronic inflammatory cardiomyopathy after fulminant myocardi.
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