ArticleCirculation2014
Are hemodynamics surrogate end points in pulmonary arterial hypertension?
Article in Circulation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 3 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
29 citing papers in PubMed, 3 syntheses or guidelines pooled it, 59 citations in OpenAlex.
- Is low-risk status a surrogate outcome in pulmonary arterial hypertension? An analysis of three randomised trials.The Lancet. Respiratory medicine · 2023Pooled it
- Heterogeneity of treatment effects by risk in pulmonary arterial hypertension.The European respiratory journal · 2023Pooled it
- Assessment of Right Ventricular Function in the Research Setting: Knowledge Gaps and Pathways Forward. An Official American Thoracic Society Research Statement.American journal of respiratory and critical care medicine · 2018Guideline
- Pulmonary Hypertension and Anastrozole (PHANTOM): A Randomized, Double-Blind, Placebo-Controlled Trial.American journal of respiratory and critical care medicine · 2024Trial
- Anastrozole in Pulmonary Arterial Hypertension. A Randomized, Double-Blind, Placebo-controlled Trial.American journal of respiratory and critical care medicine · 2017Trial
- Review
- Medication Nonadherence in Patients with Pulmonary Arterial Hypertension: The Pulmonary Hypertension Association Registry (PHAR).Annals of the American Thoracic Society · 2025Article
- Vasoreactivity and inhaled treprostinil response in interstitial lung disease pulmonary hypertension.ERJ open research · 2024Article
- Risk stratification and treatment goals in pulmonary arterial hypertension.The European respiratory journal · 2024Review
- Comparison of cardiac magnetic resonance imaging, functional and haemodynamic variables in pulmonary arterial hypertension: insights from REPAIR.ERJ open research · 2024Article
- Article
- Evolution and optimization of clinical trial endpoints and design in pulmonary arterial hypertension.Pulmonary circulation · 2023Review
- Baseline Sex Differences in Pulmonary Arterial Hypertension Randomized Clinical Trials.Annals of the American Thoracic Society · 2023Article
- The sine transform is theFrontiers in cardiovascular medicine · 2023Article
- Pulmonary hypertension in interstitial lung disease: Clinical trial design and endpoints: A consensus statement from the Pulmonary Vascular Research Institute's Innovative Drug Development Initiative-Group 3 Pulmonary Hypertension.Pulmonary circulation · 2022Review
- Clinically important changes in right ventricular volume and function in pulmonary arterial hypertension assessed with cardiac magnetic resonance imaging.Pulmonary circulation · 2022Article
- Exploring New Therapeutic Pathways in Pulmonary Hypertension. Metabolism, Proliferation, and Personalized Medicine.American journal of respiratory cell and molecular biology · 2020Article
- Clinical trial design and new therapies for pulmonary arterial hypertension.The European respiratory journal · 2019Review
- Features and Outcomes of Methamphetamine-associated Pulmonary Arterial Hypertension.American journal of respiratory and critical care medicine · 2018Article
- Arterial stiffness induces remodeling phenotypes in pulmonary artery smooth muscle cells via YAP/TAZ-mediated repression of cyclooxygenase-2.American journal of physiology. Lung cellular and molecular physiology · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
Abstract
backgroundAlthough frequently assessed in trials and clinical practice, hemodynamic response to therapy has never been validated as a surrogate end point for clinical events in pulmonary arterial hypertension (PAH). METHODS AND
resultsWe performed a patient-level pooled analysis of 4 randomized, placebo-controlled trials to determine whether treatment-induced changes in hemodynamic values at 12 weeks accounted for the relationship between treatment assignment and the probability of early clinical events (death, lung transplantation, atrial septostomy, PAH hospitalization, withdrawal for clinical worsening, or escalation in PAH therapy). We included 1119 subjects with PAH. The median (interquartile range) age was 48 years (37-59 years), and 23% were men. A total of 656 patients (59%) received active therapy (101 [15%] iloprost, 118 [18%] sitaxsentan, 204 [31%] sildenafil, and 233 [36%] subcutaneous treprostinil). Active treatment significantly lowered right atrial pressure, mean pulmonary artery pressure, and pulmonary vascular resistance and increased cardiac output and index (P<0.01 for all). Changes in hemodynamic values (except for right atrial pressure and mean pulmonary artery pressure) were significantly associated with the risk of a clinical event (P<0.02 for all). Although active treatment approximately halved the odds of a clinical event compared with placebo (P<0.001), changes in hemodynamics accounted for only 1.2% to 13.9% of the overall treatment effect.
conclusionsTreatment-induced changes in hemodynamics at 12 weeks only partially explain the impact of therapy on the probability of early clinical events in PAH. These findings suggest that resting hemodynamics are not valid surrogate end points for short-term events in PAH clinical trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.