Study Design and Rationale for the PHINDER Study: Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection.

IF 3 Q2 RESPIRATORY SYSTEM

Pulmonary Therapy Pub Date : 2025-09-01 Epub Date: 2025-07-25 DOI:10.1007/s41030-025-00307-0

Tejaswini Kulkarni, David A Zisman, Oksana A Shlobin, David G Kiely, Maral DerSarkissian, Eric Shen, Kevin M Maher, Meredith Broderick, Mary Beth Scholand

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引用次数: 0

Abstract

Introduction: A common complication of interstitial lung disease (ILD) is pulmonary hypertension (PH), which is associated with increased morbidity and mortality and worsened quality of life. In ILD, evaluating for PH is recommended prior to lung transplantation. However, this is not standardized or routinely performed in earlier stages of ILD, and guidelines lack an evidence-based approach for PH screening in this population. Furthermore, right-heart catheterization (RHC) access can be limited in many settings. The objective of PHINDER (Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection) is to prospectively develop screening strategies for PH in patients with ILD.

Methods: PHINDER is a prospective, non-interventional study that will enroll approximately 200 patients with ILD treated in a variety of settings in the United States (community centers, academic institutions, etc.). Patients must be diagnosed with ILD by high-resolution computed tomography (HRCT) and must not have a previously reported mean pulmonary arterial pressure (mPAP) > 20 mmHg. To enrich the population for PH, patients must meet additional criteria on Pulmonary Function Tests, HRCT, signs/symptoms, 6-min walk test, or echocardiography. Patients will undergo a variety of routine ILD clinical assessments. Lastly, patients receive a RHC to assess for PH, defined as mPAP > 20 mmHg with pulmonary arterial wedge pressure ≤ 15 mmHg and a pulmonary vascular resistance > 2 Wood Units. All treatment decisions are at the discretion of the provider and not influenced by study participation.

Planned outcomes: Following study completion, statistical tools will be used to derive a practical model for a screening algorithm using the variables identified in the study as most predictive of PH in patients with ILD.

Conclusions: Using a previously developed list of clinical assessments from PH and ILD experts, the PHINDER study aims to be the first prospectively enrolled study to evaluate prognostic screening strategies that can be used to develop an algorithm to predict the risk of PH in patients with ILD.

Trail registration: NCT05776225.

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PHINDER研究的研究设计和基本原理：早期发现间质性肺病患者的肺动脉高压筛查。

简介：肺间质性疾病（ILD）的常见并发症是肺动脉高压（PH），它与发病率和死亡率增加以及生活质量恶化有关。对于ILD，建议在肺移植前评估PH值。然而，在ILD的早期阶段，这并不是标准化的或常规的，并且指南缺乏在这一人群中进行PH筛查的循证方法。此外，在许多情况下，右心导管（RHC）的使用可能受到限制。PHINDER（早期发现间质性肺病患者的肺动脉高压筛查）的目的是前瞻性地制定ILD患者的PH筛查策略。方法：PHINDER是一项前瞻性、非介入性研究，将招募约200名在美国不同环境（社区中心、学术机构等）接受治疗的ILD患者。患者必须通过高分辨率计算机断层扫描（HRCT）诊断为ILD，且既往报告的平均肺动脉压（mPAP）不得低于20 mmHg。为了丰富PH人群，患者必须满足肺功能测试、HRCT、体征/症状、6分钟步行测试或超声心动图的附加标准。患者将接受各种常规ILD临床评估。最后，患者接受RHC评估PH，定义为mPAP > 20 mmHg，肺动脉楔压≤15 mmHg，肺血管阻力>2 Wood Units。所有的治疗决定都由提供者自行决定，不受参与研究的影响。计划结果：研究完成后，统计工具将使用研究中确定的最能预测ILD患者PH的变量，推导出一个实用的筛选算法模型。结论：PHINDER研究使用先前开发的PH和ILD专家的临床评估列表，旨在成为第一个前瞻性入组研究，以评估预后筛查策略，可用于开发预测ILD患者PH风险的算法。Trail registration: NCT05776225。

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来源期刊

Pulmonary Therapy Medicine-Pulmonary and Respiratory Medicine

CiteScore

5.20

自引率

3.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Pulmonary Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the use of pulmonary therapies, devices, and surgical techniques. Areas of focus include, but are not limited to: asthma; chronic obstructive pulmonary disease; idiopathic pulmonary fibrosis; pulmonary hypertension; cystic fibrosis; lung cancer; respiratory tract disorders; allergic rhinitis and other respiratory allergies; influenza, pneumococcal infection, respiratory syncytial virus and other respiratory infections; and inhalers and other device therapies. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Pulmonary Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of pulmonary therapies. Open Access All articles published by Pulmonary Therapy are open access. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. 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