Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- exercise pulmonary arterial pressure
研究概览
简要总结
This study aims to investigate the exercise profile in pulmonary hypertension patients with either pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension or pulmonary hypertension due to left heart disease and in disease control.
详细描述
This is a dual-center observational prospective study in patients with pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension, pulmonary hypertension due to left heart disease. Patients undergoing right heart catheterisation due to dyspnoe with invasive exclusion of pulmonary hypertension will be recruited as disease control.
The study comprises a 1-day screening period, followed by a right heart catheterization with exercise challenge.
The study starts with screening, information of the patients and Informed Consent Form signature at day -1. Screening and inclusion of the patient can be performed on the same day. On the day of the planned right heart catheterization based on clinical grounds, exercise right heart catheterisation (RHC) using Swan-Ganz and/or Conductance catheters with simultaneous echocardiography will be performed. End of study is defined as a complete exercise RHC. Adverse events will be assessed until 1 day after the exercise RHC.
After placement of the Swan-ganz or Conductance catheter patients will undergo an exercise challenge using the following protocol in semi-supine position until exhaustion:
- Incremental workload increase of 20Watt every 2-4 min.
- For patients not able to start a 20 Watt, initial workload can be adjusted to a minimum of 5 Watt with 5 Watt increase every 2-4 min until exhaustion
- Maximal exercise duration is 10-12 minutes
- Symptoms of dyspnoea during exercise will be rated by subjects at baseline, after 6 minutes and at maximum according to the Borg perceived dyspnoea (0-10) scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of pulmonary arterial hypertension (World Health Organization group 1)
- •Pulmonary hypertension due to left heart disease (World Health Organization group 2)
- •Chronic thromboembolic pulmonary hypertension (World Health Organization group 4)
- •Invasive exclusion of pulmonary hypertension
- •Age ≥ 18 years
- •Planned right heart catheterization based on clinical grounds
- •Stable specific PAH medications
- •Ability to undergo cycle ergometry
- •Signed informed consent
排除标准
- •Other etiologic groups of pulmonary hypertension (World Health Organization group 3, 5)
- •Unstable or severe coronary artery disease
- •Uncontrolled arterial hypertension
- •Left ventricular ejection fraction < 30%
- •Severe congenital or acquired valvular or myocardial disease
- •Progressive left heart failure
- •History of severe ventricular arrhythmias
- •Severe, terminal renal impairment
- •Severe obstructive or restrictive lung disease
- •Severe lung emphysema or interstitial lung disease
结局指标
主要结局
exercise pulmonary arterial pressure
时间窗: 1 day
mean pulmonary arterial pressure (mmHg)
exercise cardiac output
时间窗: 1 day
cardiac output (l/min);
exercise right ventriculare function
时间窗: 1 day
right ventricular strain (%)
exercise end-systolic elastance
时间窗: 1 day
end-systolic elastance (mmHg/mL)
exercise mean right atrial pressure
时间窗: 1 day
mean right atrial pressure (mmHg)
exercise right atrial function
时间窗: 1 day
right atrial strain (%)
exercise pulmonary wedge pressure
时间窗: 1 day
pulmonary arterial wedge pressure (mmHg)
exercise right atrial volume-pressure curves
时间窗: 1 day
atrial volume to pressure ratio (ml/mmHg)
exercise arterial elastance
时间窗: 1 day
arterial elastance (mmHg/mL)
exercise right volume
时间窗: 1 day
right ventricular volume (ml)
次要结局
- exercise left atrial function(1 day)
- exercise lung congestion(1 day)
- exercise left atrial volume(1 day)
- exercise hepatic backflow(1 day)