October 23, 2025Scientific ReportsOpen Access

Immunosuppressive therapy in patients with biopsy-proven inflammatory myocardial disease: a systematic review and meta-analysis

Q: What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Biopsy-proven inflammatory myocardial disease (n=594). Intervention: Immunosuppressive therapy vs. Placebo or optimal medical therapy. Primary outcome: Left ventricular ejection fraction (LVEF) at 3 months (SMD 0.97, 95% CI -0.05 to 1.99, p=>0.05).

View Full Paper

Ask AI

Bookmark

Key result

Immunosuppressive therapy fails to improve 3-month LVEF or NYHA class in biopsy-proven inflammatory myocardial disease.

SMD 0.97
95% CI -0.05 to 1.99
P>0.05
n=594

Why the study?

The study was conducted to evaluate and update the effects of immunosuppressive therapy on heart failure outcomes in patients aged 16 years or older with biopsy-proven inflammatory myocardial disease.

Does immunosuppressive therapy improve LVEF and NYHA class in patients aged 16 years or older with biopsy-proven inflammatory myocardial disease?

Comparison

Immunosuppressive therapy vs comparator

Design

Systematic review and aggregate data meta-analysis

Follow-up

3, 6, and 12 months

Authors

BSBruno StautnerDeutsches Herzzentrum der Charité MTMichał TkaczyszynHeart Failure & Transplant ASAnne SorgWroclaw Medical University

Discussion

Member takes

Implication

Does not support routine immunosuppression; leaves open the need for definitive randomized trials.

Study Design

Type

Meta-Analysis (n=594)

Structured PICO

Does immunosuppressive therapy improve LVEF and NYHA class in patients aged 16 years or older with biopsy-proven inflammatory myocardial disease?

Population

594 patients aged 16 years or older with biopsy-proven inflammatory myocardial disease (acute, chronic myocarditis, or inflammatory dilated cardiomyopathy) and heart failure, pooled from 7 RCTs.

Intervention

Immunosuppressive therapy (including regimens of prednisone, azathioprine, cyclosporine, interferon-beta-1b, or intravenous immunoglobulin) added to standard heart failure management.

Comparator

Placebo or alternative pharmacological regimen (optimal medical therapy).

Outcome

Left ventricular ejection fraction (LVEF) and New York Heart Association classification (NYHA) at 3, 6, and 12 months.surrogate

Main Result

Effect estimate: SMD 0.97 (95% CI -0.05 to 1.99)

p-value: p=>0.05

Immunosuppressive therapy does not significantly improve left ventricular ejection fraction or NYHA class in patients with biopsy-proven inflammatory myocardial disease, suggesting no routine benefit.

Limitations

High heterogeneity (I2 = 92-97%) reflecting substantial variability across studies.
Variability in patient selection, disease chronicity, viral status, endpoint definitions, and immunosuppressive regimens.
Open-label design in four studies increases the risk of performance and detection bias.
Absence of a formal publication bias assessment.
Selection bias due to biopsy-based inclusion criteria, limiting generalizability to broader patient populations.
High heterogeneity (I² = 92–97%) reflecting substantial variability across studies in patient populations and protocols
Open-label design in four of the included studies increasing the risk of performance and detection bias
Risk of bias due to missing outcome data in some studies
Unblinding of participants to their interventions raising concerns about detection bias for subjective measures like NYHA
Absence of a clearly defined analysis plan in some studies introducing potential selective reporting bias

Cite This Study

Stautner et al. (2025) conducted a meta-analysis in Biopsy-proven inflammatory myocardial disease (n=594). Immunosuppressive therapy vs. Placebo or optimal medical therapy was evaluated on Left ventricular ejection fraction (LVEF) at 3 months (SMD 0.97, 95% CI -0.05 to 1.99, p=>0.05). Immunosuppressive therapy did not significantly improve left ventricular ejection fraction at 3 months (SMD 0.97) or NYHA classification in patients with biopsy-proven inflammatory myocardial disease.

synapsesocial.com/papers/6a11d8f38095bbd48eb4cf34 https://doi.org/10.1038/s41598-025-25165-3

Topics

Myocarditis

View Full Paper

Ask AI

Bookmark

Immunosuppressive therapy in patients with biopsy-proven inflammatory myocardial disease: a systematic review and meta-analysis

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Topics

Immunosuppressive therapy in patients with biopsy-proven inflammatory myocardial disease: a systematic review and meta-analysis

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Topics

Also Consider