Primary completion dateestimated 2024-06-01→confirmed 2024-09-01
Completion date2025-06-01→2025-11-01
Start date2022-01-01→2021-11-01
Eligibility criteria+1,134 characters
Inclusion Criteriacriteria:
AgeMale or female patient aged from 18- to 80 years;
HeartLeft failureventricular NYHAdysfunction II-IV;
Patients[left withventricular myocarditisejection confirmedfraction by myocardial biopsy in the past;
Standard treatment for heart failure > 6 months;
Persistent reduction of (LVEF) <50%] ondiagnosed aby routine echocardiographic evaluationechocardiography (Simpson's biplane) notwithin older30 thandays 1before month at time of inclusionrandomization;
Chronic heart failure (lasting >6 months) unresponsive to conventional supportive therapy;
High-sensitivity cardia [...] [...]
Secondary endpoints3 to 6 entries
The increase and dynamic changes of LVIDd (mm)
The decrease and dynamic changes of hs-CRP (mg/L)
The decrease and dynamic changes of ESR (mm/H)
Primary endpoints1 entry, revised
Composite incidence of cardiovascular death or heart transplantoutcome
Study description+9 characters
[...] lone compared to prednisolone alone at long-term follow-up (1, 3, 6, 9, 12, 18, 24, 36 months).
Publications3 to 4 entries
Ammirati E, Frigerio M, Adler ED, Basso C, Birnie DH, Brambatti M, Friedrich MG, Klingel K, Lehtonen J, Moslehi JJ, Pedrotti P, Rimoldi OE, Schultheiss HP, Tschope C, Cooper LT Jr, Camici PG. Management of Acute Myocarditis and Chronic Inflammatory Cardiomyopathy: An Expert Consensus Document. Circ [...]
Study titlerevised
The Effects of Hydroxychloroquine in Patients Withwith Inflammatory Cardiomyopathy