NCT05896579招募中不适用
Phenotyping Resting and Exertional Right Ventricular Dysfunction Among Patients With Chronic Obstructive Pulmonary Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Right ventricular contractility measured by transthoracic echocardiography
研究概览
简要总结
This study plans to learn about heart function among individuals with chronic obstructive pulmonary disease (COPD). In particular, the investigators want to understand the different patterns of right ventricular response during rest and moderate- vs high-intensity exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity [FEV1/FVC] <0.7)
- •Age >= 40 years
排除标准
- •Exacerbation of COPD in the 3 months prior to enrollment
- •Change in COPD therapy in the 3 weeks prior to enrollment
- •Requirement of >6 LPM supplemental oxygen at rest
- •Requirement of >10 LPM supplemental oxygen with exertion
- •Active/uncontrolled cardiovascular disease (e.g. hypertension with blood pressure >150/100 despite antihypertensives; coronary artery disease with angina; left ventricular ejection fraction ≤40%; arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than mild in severity; tricuspid regurgitation greater than moderate in severity)
- •Volume overload (jugular vascular distension or greater than trace peripheral edema)
- •World Health Organization Functional Class IV
- •Known pulmonary hypertension with mean pulmonary artery pressure >45 mmHg
- •Untreated severe obstructive sleep apnea or obesity hypoventilation syndrome
- •Active malignancy (other than skin)
- •Medical conditions that limit exercise on an upright stationary bicycle (e.g. severe osteoarthritis, imbalance/gait instability, etc.)
- •Pregnancy
- •Body mass index <18 or >40
- •Hematocrit <25% or >55%
- •For invasive CPET, chronic anticoagulation that is unable to be held for the study visit
- •For invasive CPET, forced expiratory volume in 1 second of <20%
研究组 & 干预措施
COPD
Experimental
Participants will complete testing at rest and during moderate- and high-intensity exercise to identify patterns of right ventricular responses.
干预措施: Exercise (Behavioral)
结局指标
主要结局
Right ventricular contractility measured by transthoracic echocardiography
时间窗: Up to 1 hour
Global longitudinal strain, measured in absolute percent
次要结局
- Right ventricular systolic function measured by transthoracic echocardiography(Up to 1 hour)
- Maximum oxygen consumption (VO2max)(Up to 1 hour)
- Health-related quality of life by Short Form 36 (SF-36) questionnaire(Up to 1 hour)
- Right ventricular contractility measured by conductance catheter(Up to 1 hour)
- Physical activity measured by activity monitor(7 days)
- Plasma acylcarnitines measured via ultra-high-performance liquid chromatography coupled to mass spectrometry(Up to 1 hour)
研究者
研究点 (1)
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