Effect of Vitamin D supplementation on MyocardIal Fibrosis in PaTients with Acute Myocarditis (EDIT-AM): a multicenter, open-label, randomized controlled trial

Conditions

Acute myocarditis, Myocardial fibrosis

Brief summary

Extent of LGE (percentage of left ventricle mass) at month 6 (central core laboratory-blinded analysis)

Detailed description

Percentage of participants with at least one event of cardiovascular mortality, heart failure hospitalisation or sustained ventricular arrhythmias from baseline to month 6, Burden of PVC on 24h Holter-ECG recording at month 6, Percentage of participants without LGE at month 6, Percentage of participants with LGE <5% (percentage of left ventricle mass) at month 6, ECV at month 6, T2 mapping values at month 6, 25-OHD serum levels at week 6 and month 6, High sensitivity troponin at week 6 and month 6, NT-ProBNP at week 6 and month 6, CRP at week 6 and month 6, Percentage of participants with 25OHD >100 ng/mL at week 6 and month 6, Percentage of participants with at least one episode of symptomatic hypervitaminosis D, Percentage of participants with calcium >10.5 mg/dL at week 6 and month 6, Percentage of participants with at least one episode of symptomatic hypercalcemia, CMR LVEF at month 6, CMR left ventricular diastolic and systolic volumes at month 6, CMR detection of regional wall motion abnormalities at month 6

Related papers

No related papers found yet.

Interventions

DRUGCALCIFEDIOL MONOHYDRATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Extent of LGE (percentage of left ventricle mass) at month 6 (central core laboratory-blinded analysis)	—

Secondary

Measure	Time frame
Percentage of participants with at least one event of cardiovascular mortality, heart failure hospitalisation or sustained ventricular arrhythmias from baseline to month 6, Burden of PVC on 24h Holter-ECG recording at month 6, Percentage of participants without LGE at month 6, Percentage of participants with LGE <5% (percentage of left ventricle mass) at month 6, ECV at month 6, T2 mapping values at month 6, 25-OHD serum levels at week 6 and month 6, High sensitivity troponin at week 6 and month 6, NT-ProBNP at week 6 and month 6, CRP at week 6 and month 6, Percentage of participants with 25OHD >100 ng/mL at week 6 and month 6, Percentage of participants with at least one episode of symptomatic hypervitaminosis D, Percentage of participants with calcium >10.5 mg/dL at week 6 and month 6, Percentage of participants with at least one episode of symptomatic hypercalcemia, CMR LVEF at month 6, CMR left ventricular diastolic and systolic volumes at month 6, CMR detection of regional wall mo	—

Measure

Time frame

Percentage of participants with at least one event of cardiovascular mortality, heart failure hospitalisation or sustained ventricular arrhythmias from baseline to month 6, Burden of PVC on 24h Holter-ECG recording at month 6, Percentage of participants without LGE at month 6, Percentage of participants with LGE <5% (percentage of left ventricle mass) at month 6, ECV at month 6, T2 mapping values at month 6, 25-OHD serum levels at week 6 and month 6, High sensitivity troponin at week 6 and month 6, NT-ProBNP at week 6 and month 6, CRP at week 6 and month 6, Percentage of participants with 25OHD >100 ng/mL at week 6 and month 6, Percentage of participants with at least one episode of symptomatic hypervitaminosis D, Percentage of participants with calcium >10.5 mg/dL at week 6 and month 6, Percentage of participants with at least one episode of symptomatic hypercalcemia, CMR LVEF at month 6, CMR left ventricular diastolic and systolic volumes at month 6, CMR detection of regional wall mo

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Outcome results

None listed