NL-OMON52230已完成不适用
An international, non-drug interventional, real-world cohort of PAH patients newly initiating PAH therapy with guideline-directed assessments of disease severity - CARE PAH
Actelion Pharmaceuticals0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed ICF.
- •2. Male or female participants age >=18 years.
- •3. Symptomatic PAH in any PAH subtype.
- •4. PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior
- •to or at the index date fulfilling all of the criteria below:
- •a) Mean pulmonary artery pressure >20 mmHg, AND
- •b) Pulmonary artery wedge pressure or left ventricular end diastolic pressure
- •<=15 mmHg, AND
- •c) Pulmonary vascular resistance >= 3 Wood Units (ie, >=240 dyn*sec/cm5).
- •5. Newly initiating 1 or more PAH therapy(ies) (as monotherapy or add-on
- •therapy) at index date.
- •6. All mandated assessments must be performed and recorded at the baseline
- •visit before the initiation of the new PAH therapy.
- •7. Participants must agree to follow study protocol, including all mandated
- •visits and mandated assessments.
- •8. For the PAH-SYMPACT substudy only: Participants initiating any endothelin
- •receptor antagonist (ERA) or phosphodiesterase-5 inhibitor therapies at index
- •date must provide consent to enroll in the optional PAH-SYMPACT substudy.
- •Refusal to give consent for the optional PAH-SYMPACT substudy will not exclude
- •a participant from participation in the main study.
排除标准
- •1. Participants enrolled in any interventional clinical trial with an
- •investigational therapy in the 3-month period prior to index date.
- •2. Any PAH therapy initiated at index date was used by the participant
- •(including different route of administration of the same compound) within 3
- •months prior to index date for any reason. (Administration for vasoreactivity
- •testing is permitted.)
- •3. presence or known presence of moderate or severe obstructive lung disease
- •4. presence or known presence of moderate or severe restrictive lung disease
研究者
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