ACTRN12622000494730尚未招募未知
Exertional dyspnoea and exercise intolerance in pulmonary arterial hypertension: the role of pulmonary baroreceptors (sub-study two)
niversity of Auckland0 个研究点目标入组 15 人开始时间: 2022年3月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients with Group 1 PAH as per 6th World Symposium on Pulmonary Hypertension
- •Exertional dyspnoea (WHO functional class II and III)
- •Men and women
- •Aged 18 years or over
排除标准
- •Group 2, 3, 4, 5 pulmonary hypertension
- •Six minute walk distance < 300m
- •Dyspnoea at rest (WHO functional class IV)
- •Significant left ventricular dysfunction (Left ventricular ejection fraction <40% or significant diastolic dysfunction)
- •Obstructive or restrictive lung disease
- •o Pulmonary fibrosis or emphysema on chest radiograph or computed tomography scan
- •o Total lung capacity <80% of predicted
- •o Forced expiratory volume in first second of expiration/ forced vital capacity <70%
- •o Currently taking regular inhaled therapy for airways disease
- •Serious co-morbidities that may contribute to dyspnoea and/or reduce exercise capacity including:
- •o Severe cardiac disease (e.g., heart failure, coronary artery disease)
- •o Severe respiratory disease other than PAH (e.g., chronic obstructive pulmonary disease, interstitial lung disease)
- •o Severe obesity (Body mass index > 35 kg/m2)
- •o Severe orthopaedic impairment or rheumatologic/ connective tissue disease
- •o Significant neurological disease
- •o Significant renal or liver disease
- •o Infection or pyrexial illness
- •o Uncontrolled thyroid disorders
- •o Current active treatment for cancer
- •Presence of any contraindications to cardiopulmonary exercise testing
- •o Unstable angina or recent acute myocardial infarction
- •o Uncontrolled arrhythmias causing symptoms or haemodynamic compromise
- •o Symptomatic severe aortic stenosis
- •o Oxygen saturation <85% at rest on room air
- •o Uncontrolled heart failure
- •o Uncontrolled asthma
- •o Uncontrolled thyroid disorders
- •o Mental impairment leading to inability to cooperate
- •o Long-term oxygen therapy
- •Current pregnancy
- •Allergy or intolerance to medications used in the study (iloprost)
- •Contra-indication to study medication (iloprost)
- •Current users of recreational drugs
- •Current abusers of alcohol
- •Inability to fully or appropriately provide consent (e.g., language issue, reading capability)
- •Underlying medical conditions, which in the opinion of the Investigator place the participant at unacceptably high risk for participating in the study.
研究者
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