ArticleJACC. Asia2026
Ambrisentan for Early-Stage Low-Risk Pulmonary Arterial Hypertension: Design of the Randomized, Double-Blind, Placebo-Controlled ALEPH Trial.
Article in JACC. Asia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06987097 (Ambrisentan for the Treatment of Early-Stage Low-Risk Pulmonary Arterial Hypertension), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Ambrisentan for the Treatment of Early-Stage Low-Risk Pulmonary Arterial Hypertension: A Multicenter, Randomized, Double-Blind, Placebo-Controlled ALEPH Trial
Who cites it
1 citing paper in PubMed.
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Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEarly-stage pulmonary arterial hypertension (PAH) with mild hemodynamic abnormalities is increasingly being concerned because of the revised PAH definition. However, there is a lack of randomized controlled trials evaluating the efficacy of currently available medications in this population.
objectivesThe ALEPH (Ambrisentan for Early Low-Risk Pulmonary Arterial Hypertension) trial is designed to investigate the efficacy and safety of ambrisentan in early-stage low-risk PAH patients.
methodsThe ALEPH trial is a multicenter, randomized, double-blind, placebo-controlled clinical study. Eligible patients are diagnosed with PAH according to 2022 European Society of Cardiology and the European Respiratory Society guidelines, with mean pulmonary artery pressure >20 and <25 mm Hg, pulmonary vascular resistance >2 and ≤3 WUs, and PAWP ≤15 mm Hg by right heart catheterization, classified as low-risk, and have not previously received PAH-specific therapy. Participants are randomly assigned to receive either ambrisentan or placebo for 12 months. The primary endpoint is a composite of PAH progression. Secondary endpoints include changes in hemodynamic and echocardiographic parameters, N-terminal pro-B-type natriuretic peptide levels, World Health Organization functional class, 6-minute walk distance, and time to clinical events such as hospitalization or death. Primary analysis will be performed in the intention-to-treat population, with sensitivity analysis in the per-protocol population. Statistical analyses include Z-test for the primary endpoint, Cox proportional hazards models for time-to-event data, and analysis of covariance or Mann-Whitney U test for continuous variables.
conclusionsThe ALEPH trial aims to generate high-quality evidence regarding the efficacy and safety of ambrisentan monotherapy in early-stage, low-risk PAH. This study may provide valuable insight into early therapeutic intervention for patients with mild hemodynamic disorder. (Ambrisentan for Early Low-Risk Pulmonary Arterial Hypertension [ALEPH]; NCT06987097).
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