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Randomised placebo controlled clinical trial of efficacy of MYOcardial protection in postacute inFLAMmatory cardiac involvEment due to COVID-19 (MYOFLAME-19)
EU CTIS ID: 2024-516463-84-00
What this study is testing
The primary objective is to determine the efficacy of a combined immunosuppressive and antiremodelling therapy in COVID-19 related inflammatory cardiovascular involvement by CMR to reduce inflammatory myocardial injury compared to placebo. The primary safety objective is to demonstrate that a combined immunosuppressive and antiremodelling therapy in proposed doses in this patient population is safe.
- 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
- Participants ≥ 18 years
- Participants with documented recent COVID19 infection (> 4 weeks)
- Post-acute sequelae of SARS-CoV-2 infection (PASC) Syndrome, defined by persistence or new symptoms, not present prior to the infection.
- Cardiovascular magnetic resonance imaging (CMR) evidence of inflammatory cardiac involvement at baseline (BL) by any of the following criteria: o Increased native T1≥ 1130 ms at 3.0 Tesla (or 1030 ms at 1.5 Tesla) and/or; o Increased native T2 ≥39.5 ms at 3.0 Tesla (or 49.5 at 1.5 Tesla)and/or o present non-ischaemic myopericardial Late gadolinium enhancement (LGE) and/or; o Left ventricular ejection fraction (LVEF) ≥45 - ≤50%.
- Willingness to comply with the study procedures and study protocol.
You likely can't join if
- Severe course of acute COVID illness requiring hospitalisation
- Exceeding scanner bore and table-holding capacity: Weight >125 kg, BMI > 35 kg/m2
- Contraindications to contrast-enhanced CMR imaging, e.g. a. MR-unsafe implantable device b. known allergy to gadolinium-based contrast agent (CBGA)
- For female participants: a. Pregnant or breastfeeding women b. Women of childbearing potential not willing to use highly effective contraception (as defined in 18.2.13)
- Known alcohol, drug or chemical abuse
- Participants currently participating in an investigational study or for whom participation is planned.
See the full eligibility criteria
- Participants ≥ 18 years
- Participants with documented recent COVID19 infection (> 4 weeks)
- Post-acute sequelae of SARS-CoV-2 infection (PASC) Syndrome, defined by persistence or new symptoms, not present prior to the infection.
- Cardiovascular magnetic resonance imaging (CMR) evidence of inflammatory cardiac involvement at baseline (BL) by any of the following criteria: o Increased native T1≥ 1130 ms at 3.0 Tesla (or 1030 ms at 1.5 Tesla) and/or; o Increased native T2 ≥39.5 ms at 3.0 Tesla (or 49.5 at 1.5 Tesla)and/or o present non-ischaemic myopericardial Late gadolinium enhancement (LGE) and/or; o Left ventricular ejection fraction (LVEF) ≥45 - ≤50%.
- Willingness to comply with the study procedures and study protocol.
- Severe course of acute COVID illness requiring hospitalisation
- Exceeding scanner bore and table-holding capacity: Weight >125 kg, BMI > 35 kg/m2
- Contraindications to contrast-enhanced CMR imaging, e.g. a. MR-unsafe implantable device b. known allergy to gadolinium-based contrast agent (CBGA)
- For female participants: a. Pregnant or breastfeeding women b. Women of childbearing potential not willing to use highly effective contraception (as defined in 18.2.13)
- Known alcohol, drug or chemical abuse
- Participants currently participating in an investigational study or for whom participation is planned.
- Unable to provide written informed consent.
- Participants with CMR evidence of structural heart disease or incidental heart rhythm abnormalities will be advised to see their own doctor for further investigation.
- Participants currently participating in an investigational study or for whom participation is planned.
- Unable to provide written informed consent
- Known allergy to or intolerance of the study medications
- Symptomatic hypotension (systolic blood pressure less than 90 mm Hg), not reversible with oral hydration
- Any previous or current use of ACE inhibitors, AR Blockers
- Any previous oral prednisolone, or any other immunosuppressive or biological treatment (within prior 10 weeks)
- History or CMR evidence of preexisting heart disease, including: a. Known cardiac impairment with LVEF ≤44% b. Congestive heart failure (NYHA III-IV) c. Active heart failure treatment d. Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease e. Persistent or permanent atrial fibrillation or significant heart rhythm abnormalities. f. Congenital or clinically relevant valvular heart disease (moderate or severe) g. Specific cardiomyopathy (hypertrophic, hypertensive heart disease, amyloidosis, previous myocarditis, non-ischaemic dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, noncompaction cardiomyopathy, etc).
- Known significant concomitant diseases that are likely to interfere with the evaluation of the participant’s safety and of the study outcome (e.g. diabetes, lung or hepatic disease, epilepsy, psychiatric disorders, renal disease with a current estimated GFR <30 mL/min/1.73 m² using MDRD formula, chronic systemic infection or immunocompromise)
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.