Losartan plus prednisolone did not significantly improve left ventricular ejection fraction compared to placebo in post-COVID syndrome (difference 0.74 pp; 95% CI -0.14 to 1.62; p=0.10).
RCT (n=279)
Double-blind
1:1
Yes
Does losartan plus prednisolone improve change in left ventricular ejection fraction in participants with post-COVID syndrome and inflammatory cardiac involvement?
In patients with post-COVID syndrome and CMR-defined cardiac inflammation, 16 weeks of losartan plus prednisolone did not significantly improve left ventricular ejection fraction compared to placebo.
Mean Difference: 0.74 (95% CI -0.14–1.62)
p-value: p=0.10
Abstract Persistent cardiac symptoms are common in post-COVID syndrome, even without structural heart disease. Evidence implicates immune dysregulation, endothelial dysfunction and low-grade cardiovascular inflammation. Yet no targeted treatment exists. Myoflame-19 is a multicenter, double-blind clinical trial of 279 participants with inflammatory cardiac involvement defined by cardiovascular magnetic resonance, randomized 1:1 to losartan plus prednisolone ( n = 139 ) or matching placebos ( n = 140 ) for 16 weeks. The modified intention-to-treat population comprised 124 and 122 participants. The primary endpoint, change in left ventricular (LV) ejection fraction, was neutral: between-group difference 0.74 percentage points (pp), 95%CI −0.14 to 1.62, p = 0.10, unpaired t-test; supportive baseline-adjusted ANCOVA 0.99, 95%CI 0.15-1.83, p = 0.021. Among prespecified secondary endpoints, several symptom and imaging measures showed numerical differences favoring intervention, including Average Symptom Score components (modified Canadian Chest Pain Scale −4.8 pp, 95%CI −17.3 to 7.6; NYHA class −8.1 pp, −20.6 to 4.3; Long COVID symptom burden −7.7 pp, −18.9 to 3.6), native T1 and T2 values (native T1 −2.46 ms, −8.35 to 3.42; native T2 −0.31 ms, −1.16 to 0.53), and LV end-diastolic volume ( + 1.45 ml/m², −0.09 to 3.00); however, confidence intervals included the null value and these findings should be regarded as hypothesis-generating.Treatment was safe and well-tolerated. These findings indicate a neutral treatment effect on the primary endpoint. They inform targeted immunomodulation and design of future trials in post-COVID syndrome and inflammatory cardiac involvement. Trial registration: EudraCT 2022-001682-12; NCT05619653.
“The manuscript is well written, the introduction and aim are easy to follow, and the results are somewhat easy to follow. Notwithstanding, this reviewer is somewhat uneasy about the presentation of the changes in anatomical and functional measurements.”
Timely RCT on post-COVID cardiac issues.
Püntmann et al. (Thu,) conducted a rct in Post-COVID syndrome and inflammatory cardiac involvement (n=279). Losartan plus prednisolone vs. Matching placebos was evaluated on Change in left ventricular (LV) ejection fraction (between-group difference 0.74 percentage points, 95% CI -0.14 to 1.62, p=0.10). Losartan plus prednisolone did not significantly improve left ventricular ejection fraction compared to placebo in post-COVID syndrome (difference 0.74 pp; 95% CI -0.14 to 1.62; p=0.10).