COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05619653

Valentina Puntmann, MD, PhD

CVI-Myoflame@kgu.de

2022-11-17

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Long covid

inclusion criteria: patients ≥ 18 years patients with documented recent covid19 infection (>4 weeks) pasc syndrome, defined by persistence or new symptoms, not present prior to the infection. cmr evidence of inflammatory cardiac involvement at bl by any of the following criteria: increased native t1≥ 1130 ms at 3.0 tesla (or 1030 ms at 1.5 tesla) and/or; increased native t2 ≥39.5 ms at 3.0 tesla (or 49.5 at 1.5 tesla) and/or present non-ischaemic myopericardial lge and/or; lvef ≥45 - ≤50%. willingness to comply with the study procedures and study protocol

severe 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 prior 10 weeks) history or cmr evidence of pre-existing significant heart disease, including: known cardiac impairment with lvef ≤44% congestive heart failure (nyha iii-iv) active heart failure treatment established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease persistent or permanent atrial fibrillation or significant heart rhythm abnormalities congenital or clinically relevant valvular heart disease (moderate or severe) specific cardiomyopathy (hypertrophic, hypertensive heart disease, amyloidosis, previous myocarditis, non-ischaemic dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, non-compaction cardiomyopathy, etc). known significant concomitant diseases that are likely to interfere with the evaluation of the patient'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) exceeding scanner bore and table-holding capacity: weight >125 kg, bmi > 35 kg/m2 contraindications to contrast-enhanced cmr imaging, e.g. mr-unsafe implantable device known allergy to gadolinium-based contrast agent (cbga) for female participants: pregnant or breastfeeding women persons of childbearing potential not willing to use effective contraception (defined as pearl index <1 - e.g. contraceptive pill, iud) known alcohol, drug or chemical abuse patients currently participating in an investigational study or for whom participation is planned. unable to provide written informed consent patients with cmr evidence of structural heart disease or incidental heart rhythm abnormalities will be advised to see their own doctor for further investigation.

2

Valentina Puentmann

18

65

Austria;Germany

Patients recovered from covid

N/A

280

Left ventricular ejection fraction

None

Phase 3

[{"arm_notes": "nan", "treatment_id": 2650, "treatment_name": "Losartan+prednisolone", "treatment_type": "Cardiovascular agents+corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]