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Effect of Calcifediol Monohydrate on Myocardial Fibrosis in Patients with Acute Myocarditis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial involves people who have experienced Acute myocarditis, a sudden inflammation of the heart muscle, and who also have low blood levels of vitamin D. The study tests whether giving a vitamin D supplement called calcifediol monohydrate can reduce myocardial fibrosis, which is scarring of the heart tissue that may affect how well the heart works. The supplement is taken by mouth in a set dose.

The purpose is to determine if vitamin D supplementation changes the amount of scar tissue seen after six months. Participants are randomly assigned to receive either the supplement or a placebo and are followed for six months. During the study they undergo a special heart scan called LGE CMR that shows scar tissue, blood tests for 25-OHD (the form of vitamin D measured in the blood), and a 24‑hour heart rhythm monitor that records PVC (extra heartbeats). Visits are scheduled at the start, at six weeks, and at six months to check blood levels, scan results, and any side effects.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment and start medication
After joining the study you will attend a baseline visit at the study center.
During this visit a cardiac mri (cmr) scan will be performed; this scan creates detailed pictures of the heart to measure any scar tissue (myocardial fibrosis).
Blood samples will be taken to measure vitamin d level, heart‑related proteins (troponin and nt‑probnp), an inflammation marker (crp), and calcium concentration.
A 24‑hour holter‑ecg monitor will be placed on your chest to record your heart rhythm continuously for one day.
You will receive the study medication, calcifediol monohydrate, to be taken orally at a dose of 266 micrograms each day.
Step 2
Daily medication administration
You will take the oral dose of 266 micrograms of calcifediol once each day for the entire study period, which lasts six months.
The medication is intended to increase your vitamin d level and is provided in tablet form that can be swallowed with water.
Step 3
Week 6 safety and laboratory visit
Six weeks after starting the medication you will return for a follow‑up visit.
Blood will be drawn again to check vitamin d level, troponin, nt‑probnp, crp, and calcium.
The results are used to monitor for possible excess vitamin d (hypervitaminosis d) or high calcium (hypercalcemia), which could require adjustment of the medication.
No additional imaging studies are scheduled at this visit.
Step 4
Month 6 final assessment
At six months you will undergo a final visit that includes another cardiac mri scan to evaluate the extent of myocardial fibrosis and other heart measurements.
A repeat 24‑hour holter‑ecg monitor will be used to assess any changes in heart rhythm.
Blood samples will again be taken to measure vitamin d, troponin, nt‑probnp, crp, and calcium.
The information collected at this visit is compared with the baseline data to determine the effect of the vitamin d supplementation.

Who can join the trial?

5 criteria

Be 18 years old or older and have been admitted to the hospital with acute myocarditis (inflammation of the heart muscle).
Have the diagnosis confirmed by cardiac magnetic resonance imaging (CMR), a special heart scan.
Show a left ventricular ejection fraction of 40% or higher on the CMR scan, meaning the left side of the heart pumps at least 40% of its blood with each beat.
Show late gadolinium enhancement (LGE) on the CMR scan, which indicates areas of heart tissue damage.
Have a blood level of 25‑hydroxyvitamin D (25OHD) lower than 25 ng/mL, indicating low vitamin D status.

Who cannot join the trial?

19 criteria

Allergy or intolerance to calcifediol (a form of vitamin D) or any of its ingredients.
Having any type of cardiomyopathy such as dilated, hypertrophic, or arrhythmogenic (these are diseases that affect the heart muscle’s size or rhythm).
Having a congenital heart disease (a heart defect that is present from birth).
Having had an acute coronary syndrome (like a heart attack) or heart surgery within the past three months.
Being pregnant or breastfeeding.
Having cancer or any other life‑threatening illness.
Any reason that makes CMR (cardiac magnetic resonance imaging, a special heart MRI) unsafe, including allergy to gadolinium contrast media (a dye used during the scan).
Any other medical or physical condition that the study doctor decides makes participation unsuitable.
Already taking vitamin D supplements.
Currently enrolled in another clinical trial for acute myocarditis.
Unable to sign a written informed consent form or unable to give a phone number for contact.
Having hypercalcemia (blood calcium level higher than 10.5 mg/dL) or hypercalciuria (excess calcium in the urine).
Having calcium nephrolithiasis (kidney stones made of calcium).
Acute myocarditis that is complicated by hemodynamic instability (unstable blood pressure or heart function), sustained ventricular tachycardia (rapid heart rhythm originating from the lower chambers), or new problems with the heart’s electrical conduction.
Acute myocarditis caused by immune checkpoint inhibitors (certain cancer drugs).
Having eosinophilic myocarditis (a type of heart inflammation involving a specific white blood cell).
Having giant cell myocarditis (a rare, severe form of heart inflammation).
Having granulomatous disorders such as tuberculosis or sarcoidosis (diseases that form small clusters of immune cells in tissues).
Having a systemic autoimmune disorder (a disease where the immune system attacks the body’s own tissues).

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Verified sites

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Hospital Universitario Hm Monteprincipe
Verified
Boadilla Del Monte, Spain
Hospital Universitario Virgen De La Victoria
Verified
Malaga, Spain

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Investigated drugs

Calcifediol monohydrate is an oral form of vitamin D that the study gives to patients with acute myocarditis who have low vitamin D levels. The medicine helps increase the amount of active vitamin D in the body, which may influence how the heart heals after inflammation. In this trial, participants take the supplement for several months, and researchers check whether it reduces scar tissue (myocardial fibrosis) in the heart as seen on MRI scans. The goal is to see if improving vitamin D status can lead to better heart recovery.

What is already known about the treatment

CALCIFEDIOL MONOHYDRATE - It is taken by mouth, usually as a tablet or capsule, delivering 266 µg of calcifediol per dose. Calcifediol is already approved and widely used to treat low vitamin D levels and related bone problems, and it is well described in medical literature. The drug works by being converted in the body to the active form of vitamin D, which helps the body absorb calcium and supports normal heart and muscle function. It belongs to the vitamin D family of nutrients and is classified as a vitamin D analog.

Investigated diseases

Myocardial fibrosis
A condition where scar tissue slowly builds up in the heart muscle, making the tissue less flexible and less able to contract properly. Over time the amount of scar can increase, gradually affecting the heart’s pumping efficiency.
Acute myocarditis
An inflammation of the heart muscle that begins suddenly, often after an infection or immune response. The inflammation can cause swelling and damage to heart cells, and as the episode resolves, the heart may return to normal or retain some lingering changes.