Eisenmenger syndrome and pulmonary arterial hypertension (PAH) due to unrepaired congenital shunts, including atrial septal defect (ASD), ventricular septal defect (VSD) and patent ductus arteriosus (PDA), remain life-threatening conditions despite advances in congenital heart disease (CHD) care. In this population, vasodilator-based therapies effective in other forms of PAH have shown limited benefit, and no disease-modifying treatment has been established. Sotatercept, an activin-signalling inhibitor, improved exercise capacity and haemodynamics in phase 2/3 PAH trials; however, patients with unrepaired CHD, including Eisenmenger syndrome, were excluded. The efficacy and safety of sotatercept in this population remain unknown.

The SuMILE trial is a prospective, exploratory, multicentre, open-label, randomised, controlled trial conducted at 11 Japanese tertiary centres. 36 adults with vasodilator-resistant PAH due to unrepaired ASD, VSD or PDA, including Eisenmenger syndrome, will be randomised 2:1 to sotatercept add-on therapy plus vasodilator-based PAH therapy versus vasodilator-based PAH therapy alone. Sotatercept will be administered subcutaneously every 3 weeks in accordance with label-approved dose-modification rules for haemoglobin and platelet changes. The primary endpoint is the change in 6-min walk distance from baseline to week 24. Key clinical events will be independently adjudicated. Secondary endpoints include all-cause mortality or lung transplantation; pulmonary hypertension-related hospitalisation or initiation of parenteral prostacyclin and changes in WHO functional class, N-terminal pro-brain natriuretic peptide and emPHasis-10. Exploratory endpoints include genotype, right heart catheterisation and cardiac MRI parameters. The primary analysis will use ANCOVA, adjusting for baseline 6-min walk distance and randomisation stratum in the intention-to-treat population.

The protocol has been reviewed and approved by the certified central review board (Kyushu University Hospital Clinical Ethics Review Board) and participating institutions. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, scientific conferences and trial registries.

Japan Registry of Clinical Trials no. 1071250069; ClinicalTrials.gov NCT07356778. Protocol version and date: V.1.3; 23 October 2025

The literature examining direct-to-consumer (DTC) commercial virtual care has expanded rapidly over the past decade. Our objective was to synthesise the nature and range of evidence on DTC commercial virtual care.

Scoping review.

MEDLINE ALL, EMBASE Classic+Embase, CINAHL, HealthSTAR, PsycINFO, CENTRAL and grey literature sources.

We included original research studies published in English or French between 1 January 2016 and 30 April 2025 that assessed DTC commercial virtual care in all contexts and in all populations.

Screening titles and abstracts, and full-text manuscripts, and extracting data was done in duplicate. We analysed quantitative data using descriptive statistics and reported findings in tables. We provided a narrative summary of textual data.

After excluding duplicates, we identified 8055 studies for title and abstract screening; 691 articles for full-text screening; and 103 studies meeting our inclusion criteria. 32 studies (31.1%) reported financial ties to the virtual care industry. 67 (65.0%) studies were conducted in the USA. Studies were largely quantitative (87/103 (84.5%)) or mixed methods (8/103 (7.8%)) studies and used cross-sectional (85/95 (89.5%)) designs. Most quantitative studies were descriptive, reporting on quality of care, health outcomes, platform characteristics and patient views, with only 24 of the 95 quantitative studies (25.3%) including a control or comparison group. 18 of these 24 studies (75.0%) compared the quality of care, costs and/or utilisation to other models of care and reported variable findings. The rest compared patient characteristics. Few studies assessed clinician perspectives or addressed privacy-related ethical concerns.

Despite a large number of studies assessing DTC commercial virtual care, we have little insight into impacts on quality of care, health outcomes, health system utilisation and privacy-related ethical concerns. The financial ties with industry suggest that there may be bias in the body of research literature.