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Effect of Vitamin D on MyocardIal Fibrosis in Acute Myocarditis
EU CTIS ID: 2025-523092-33-00
What this study is testing
Evaluate the effect of Vitamin D supplementation on myocardial fibrosis at 6 months follow-up assessed by LGE CMR in patients with uncomplicated AM and low levels of 25OHD
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients admitted with AM aged ≥18 years.
- Diagnosis confirmed by CMR.
- Left ventricular ejection fraction ≥40% on CMR.
- Presence of LGE on CMR
- 25OHD levels <25 ng/mL
You likely can't join if
- Known allergy or intolerance to calcifediol or its components
- Dilated, hypertrophic or arrhythmogenic cardiomyopathy
- Congenital heart disease
- Acute coronary syndrome (ACS) or cardiac surgery within the last 3 months
- Pregnant or lactating women
- Cancer or any other life-threatening condition
See the full eligibility criteria
- Patients admitted with AM aged ≥18 years.
- Diagnosis confirmed by CMR.
- Left ventricular ejection fraction ≥40% on CMR.
- Presence of LGE on CMR
- 25OHD levels <25 ng/mL
- Known allergy or intolerance to calcifediol or its components
- Dilated, hypertrophic or arrhythmogenic cardiomyopathy
- Congenital heart disease
- Acute coronary syndrome (ACS) or cardiac surgery within the last 3 months
- Pregnant or lactating women
- Cancer or any other life-threatening condition
- Any contraindication to CMR procedures, including allergy or intolerance to gadolinium contrast media
- Any other medical or physical condition considered unappropriated by a study physician
- Patients already receiving Vitamin D supplementation
- Participation in other AM clinical trials
- Unable to provide written informed consent (either personally or through a designated legal representative) or to provide a contact telephone number.
- Hypercalcemia (>10.5 mg/dL) or hypercalciuria
- Calcium nephrolithiasis
- AM complicated with hemodynamic instability, sustained ventricular tachycardia or new-onset conduction abnormalities
- Immune checkpoint inhibitors-associated AM
- Eosinophilic myocarditis
- Giant Cell myocarditis
- Granulomatous disorders (tuberculosis, sarcoidosis)
- Systemic Autoimmune Disorders
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.