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Congenital Heart Disease Studies · Journal article
International Journal of Cardiology Congenital Heart Disease · June 29, 2026
Early or partial results. Treat as a signal, not a conclusion.
This bibliometric review of 160 medication studies in congenital heart disease (59,208 participants, 2000–2024) documents that only 29.4% were randomized controlled trials and reveals declining publication output since 2013. The analysis identifies a narrow evidence base, dominated by pulmonary-hypertension drugs (58.1% of publications) and single-center designs, highlighting a substantial gap in robust pharmacotherapy evidence for CHD.
Systematic bibliometric analysis. Medication studies in congenital heart disease published 2000–2024; excluded genetic-associated cardiovascular abnormalities and isolated pulmonary hypertension.. Intervention: Medication interventions in congenital heart disease (characterized by drug class and study design). n = 160. Not specified.
160 CHD medication studies involving 59,208 participants across 24.5 years (2000–2024) Only 29.4% (n = 47) of trials were RCTs Sex reported for 20,092 participants; 10,514 (52.3%) were women
Bibliometric analysis does not assess efficacy, safety, or clinical outcomes of specific medications
This analysis demonstrates a critical shortage of robust randomized evidence in congenital heart disease pharmacotherapy, with the majority of studies being non-RCT, single-center, and concentrated on a narrow disease spectrum (pulmonary hypertension). Clinicians and researchers should recognize the weak evidence base for most CHD medication decisions and prioritize investment in well-designed, multicenter RCTs across broader CHD phenotypes.
A bibliometric analysis characterizing the landscape of medication studies in congenital heart disease, documenting low RCT prevalence (29.4%) and publication trends, but offering no direct clinical efficacy data or intervention comparisons.
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This analysis demonstrates a critical shortage of robust randomized evidence in congenital heart disease pharmacotherapy, with the majority of studies being non-RCT, single-center, and concentrated on a narrow disease spectrum (pulmonary hypertension). Clinicians and researchers should recognize the weak evidence base for most CHD medication decisions and prioritize investment in well-designed, multicenter RCTs across broader CHD phenotypes.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Background: Randomized controlled trials represent robust foundational material for evidence-based clinical practice in cardiology; however, such trials appear to be scarce in congenital heart disease (CHD). No bibliometric analysis has formally quantified nor characterized this gap in the literature, nor examined the impact of existing medication studies in CHD patients. Objectives: This investigation aimed to evaluate and characterize existing medication studies in congenital heart disease. Methods: PubMed, Embase, Web of Science, Cochrane Library, Emcare and Academic Search Premier were searched (Jan 2000-May 2024) for CHD drug studies. Trials focusing on genetic conditions associated with cardiovascular abnormalities (e.g. Marfan syndrome) and pulmonary hypertension not associated with congenital heart disease were excluded.PROSPERO ID: CRD420251073438. Results: A total of 160 CHD medication studies involving 59,208 participants were included, spanning a study period of 24.5 years (2000-2024). Sex was reported for 20,092 participants; 10,514 (52.3%) were women. Only 29.4% (n = 47) of trials were RCTs. Time-series breakpoint analysis showed an inflection in annual publication output in 2013 (p = 0.009), with growth before and contraction thereafter. Pulmonary-hypertension drugs accounted for 58.1% of publications. Collectively, industry-funded trials were over twice as likely to be RC type trials (56.7% vs 23.1% in non-industry funded studies). Conclusions: Contemporary CHD pharmacotherapy research is limited in spectrum/demographics and appears to have been plateauing globally since 2013. Many studies are single-center, pulmonary-hypertension-focused and not placebo-controlled. There is a need to develop a broader disease evidence-base for medication interventions in CHD.
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