Raising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in right ventricular ejection fraction
研究概览
简要总结
In this prospective long term feasibility study we examine whether a goal oriented therapeutic strategy that is able to preserve right ventricular function will result in improved clinical outcome in patients with pulmonary arterial hypertension. We hypothesize that right ventricular function can only be preserved when early and aggressive medical combination therapy not only reduces pulmonary vascular resistance but also pulmonary pressures.
详细描述
Rationale:
The current strategy in patients with pulmonary arterial hypertension (PAH)is to improve exercise capacity which can be achieved by decreasing pulmonary vascular resistance (PVR) and subsequently increasing cardiac output (CO). Despite this load reduction, a substantial proportion of patients show progressive right ventricular (RV) dysfunction leading to clinical worsening and death. A possible explanation is that current therapies show a relatively modest reduction in PVR, leaving mean pulmonary artery pressure (mPAP) unchanged. As a consequence RV work, defined as the product of CO and mPAP increases, contributing to progressive RV dysfunction.
Hypothesis:
A goal oriented therapeutic strategy that is able to preserve RV function will result in improved clinical outcome. RV function can only be preserved when early and aggressive combination therapy not only reduces PVR but also mPAP.
Study questions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic or heritable pulmonary arterial hypertension
- •New York Heart Association (NYHA) functional class II or III
排除标准
- •Other causes of pulmonary arterial hypertension (i.e. collagen vascular disease, congenital heart disease, chrono-thromboembolic pulmonary hypertension, pulmonary venous hypertension, left heart failure, hypoxemic lung disease)
- •Pulmonary arterial hypertension targeted therapies before study inclusion
研究组 & 干预措施
Upfront combination therapy
Combination of an ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)
干预措施: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan) (Drug)
结局指标
主要结局
Change in right ventricular ejection fraction
时间窗: 4,12, 24 months of follow-up
The primary endpoint will be change in right ventricular ejection fraction (RVEF) during 2 years of follow-up.
次要结局
- pulmonary vascular resistance(4,12, 24 months of follow-up)
- Exercise capacity(4,8, 12, 24 months of follow-up)
- New York Heart Association functional class(4,8, 12, 24 months of follow-up)
- mPAP(4,12, 24 months of follow-up)
- Cardiac output in L/min (Thermodilution method)(4,8, 12, 24 months of follow-up)
研究者
A. Vonk Noordegraaf
Clinical Professor, Principal Investigator
Amsterdam UMC, location VUmc