Trial reportEuropean heart journal2017
SERAPHIN haemodynamic substudy: the effect of the dual endothelin receptor antagonist macitentan on haemodynamic parameters and NT-proBNP levels and their association with disease progression in patients with pulmonary arterial hypertension.
Trial report in European heart journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.
What it found
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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
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 75 citations in OpenAlex.
- Efficacy and safety of macitentan for pulmonary hypertension: A meta-analysis.The clinical respiratory journal · 2023Pooled it
- Benefits of Macitentan in Patients with Pulmonary Hypertension: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Global heart · 2023Pooled it
- Long-term inhaled treprostinil for pulmonary hypertension due to interstitial lung disease: INCREASE open-label extension study.The European respiratory journal · 2023Trial
- Selection of Endothelin Receptor Antagonists in the Treatment of Pulmonary Arterial Hypertension: A Comprehensive Narrative Review.Advances in therapy · 2026Review
- Macitentan Plus Tadalafil Single-Tablet Combination Therapy in Chinese Patients With Pulmonary Arterial Hypertension: A Subgroup Analysis of the A DUE Study.Pulmonary circulation · 2025Article
- Dual ETFundamental & clinical pharmacology · 2025Article
- Risk stratification and treatment goals in pulmonary arterial hypertension.The European respiratory journal · 2024Review
- SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation.Pulmonary circulation · 2024Article
- Impact of rapid sequential combination therapy on distinct haemodynamic measures in newly diagnosed pulmonary arterial hypertension.ESC heart failure · 2024Article
- Macitentan in the Young-Mid-term Outcomes of Patients with Pulmonary Hypertensive Vascular Disease treated in a Pediatric Tertiary Care Center.Paediatric drugs · 2023Article
- Review
- Evolution and optimization of clinical trial endpoints and design in pulmonary arterial hypertension.Pulmonary circulation · 2023Review
- The Consistent Effectiveness and Safety of Macitentan Therapies Across Idiopathic and Congenital Heart Disease-Associated PulmonaryArterial Hypertension: A Single-Center Experience.Anatolian journal of cardiology · 2022Article
- Prognostic impact of follow-up pulmonary vascular resistance in pulmonary arterial hypertension.Open heart · 2022Article
- Circulating Blood-Based Biomarkers in Pulmonary Hypertension.Journal of clinical medicine · 2022Review
- Clinical application of pulmonary vascular resistance in patients with pulmonary arterial hypertension.Journal of cardiothoracic surgery · 2021Review
- Observational
- The Transition From Ambrisentan to Macitentan in Patients With Pulmonary Arterial Hypertension: A Real-word Prospective Study.Frontiers in pharmacology · 2021Article
- Management of Pulmonary Arterial Hypertension Patients with World Health Organization Functional Class II.Acta Cardiologica Sinica · 2020Review
- Safety and efficacy of the endothelin receptor antagonist macitentan in pediatric pulmonary hypertension.Cardiovascular diagnosis and therapy · 2020Article
Corrections and comments
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Authors and funding
15 authors at 11 institutions in 11 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Aims: The effect of macitentan on haemodynamic parameters and NT-proBNP levels was evaluated in pulmonary arterial hypertension (PAH) patients in the SERAPHIN study. Association between these parameters and disease progression, assessed by the primary endpoint (time to first morbidity/mortality event), was explored. Methods and results: Of the 742 randomized patients, 187 with right heart catheterization at baseline and month 6 participated in a haemodynamic sub-study. Prespecified endpoints included change from baseline to month 6 in cardiac index (CI), right atrial pressure (RAP), mean pulmonary arterial pressure (mPAP), pulmonary vascular resistance (PVR), mixed-venous oxygen saturation, and NT-proBNP. Exploratory analyses examined associations between CI, RAP, and NT-proBNP and disease progression using the Kaplan-Meier method and Cox regression models. Macitentan improved CI, RAP, mPAP, PVR and NT-proBNP vs. placebo at month 6. Absolute levels of CI, RAP and NT-proBNP at baseline and month 6, but not their changes, were associated with morbidity/mortality events. Patients with CI > 2.5 L/min/m2, RAP < 8 mmHg, or NT-proBNP < 750 fmol/ml at month 6 had a lower risk of morbidity/mortality than those not meeting these thresholds (HR 0.49, 95% CL 0.28-0.86; HR 0.72, 95% CL 0.42-1.22; and HR 0.22, 95% CL 0.15-0.33, respectively). Conclusions: For all treatment groups, baseline and month 6 values of CI, RAP, and NT-proBNP, but not their changes, were associated with morbidity/mortality events, confirming their relevance in predicting disease progression in patients with PAH. By improving those parameters, macitentan increased the likelihood of reaching threshold values associated with lower risk of morbidity/mortality.
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