EUCTR2022-001682-12-AT
Active, not recruiting
Phase 1
Randomised placebo controlled clinical trial of efficacy of MYOcardial protection in patients with postacute inFLAMmatory cardiac involvEment due to COVID-19 (MYOFLAME-19) - MYOFLAME-19
Goethe University Frankfurt0 sites280 target enrollmentDecember 22, 2022
ConditionsInflammatory cardiovascular involvement due to COVID-19, defined by Cardiovascular magnetic resonance imagingMedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: LLTClassification code 10007650Term: Cardiovascular disorder NOSSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Virus Diseases [C02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Inflammatory cardiovascular involvement due to COVID-19, defined by Cardiovascular magnetic resonance imaging
- Sponsor
- Goethe University Frankfurt
- Enrollment
- 280
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •Severe course of acute COVID illness requiring hospitalisation
- •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 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
Outcomes
Primary Outcomes
Not specified
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