NCT05036252进行中（未招募）不适用
A Pilot Study of Cardiopulmonary Exercise Testing in Patients With Left Ventricular Systolic Dysfunction Receiving HER2-Targeted Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Baseline VO2peak in participants with HER2-positive breast cancer
研究概览
简要总结
The purpose of this study is to find out how much oxygen is used during a cardiopulmonary exercise test (CPET) in women who have mild cardiotoxicity after standard treatment for HER2-positive breast cancer, and to see whether the results of this test can be used to predict how well participants' heart and lungs will work if they continue to receive this kind of treatment.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosed with a HER2-positive solid tumor (stage I-IV)
- •Left ventricular dysfunction prior to the start of HER2-targeted therapy, defined by a LVEF < 53% (or lower limit of normal), or diagnosed with mild cardiotoxicity associated with HER2-targeted therapy, defined by an absolute decrease in LVEF ≥ 10% from pre-treatment to < 53%
- •Planning to undergo treatment with HER2-targeted therapy (e.g. trastuzumab, pertuzumab, or ado-trastuzumab) for a minimum of 3 months (i.e. 4 cycles administered every 3 weeks).
- •Willing and able to comply with the requirements of the protocol
排除标准
- •Symptomatic heart failure (New York Heart Association Class III or IV)
- •Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing:
- •Acute myocardial infarction (within 30 days of any planned study procedures),
- •Unstable angina
- •Uncontrolled arrhythmias causing symptoms or hemodynamic compromise,
- •Symptomatic severe aortic stenosis
- •Recurrent syncope
- •Active endocarditis
- •Acute myocarditis or pericarditis
- •Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures)
- •Thrombosis of lower extremities (within 3 months of any planned study procedures)
- •Suspected dissecting aneurysm
- •Uncontrolled asthma
- •Pulmonary edema
- •Room air desaturation at rest ≤ 85%
- •Respiratory failure
- •Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
- •Mental impairment leading to inability to cooperate.
- •Enrollment onto any other interventional investigational study
- •Inability to provide informed consent
结局指标
主要结局
Baseline VO2peak in participants with HER2-positive breast cancer
时间窗: At baseline
The primary purpose is to evaluate baseline VO2peak in patients with HER2-positive solid tumors and left ventricular systolic dysfunction
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Using Exercise-testing to Explore Patient Differences in Severe AsthmaAsthmaNCT05733143Queen's University, Belfast64
已完成
1 期
Imaging Lung Function Using Oxygen Enhanced MRICOPDCystic FibrosisSmall Airways DiseaseEmphysemaAsthmaNCT01731015Hal C Charles15
招募中
不适用
CPET in Myocardial IschemiaMyocardial IschemiaNCT04067700Kuopio University Hospital100
招募中
不适用
Development & Validation of Preoperative Objective Physiological EvaluationCardiorespiratory FitnessNCT05092126Duke University100
已完成
不适用
CPEX as an assessment tool for prediction of postoperative outcome after major abdominal surgeryCTRI/2015/06/005937Institute of Liver and Biliary Sciences25