Chronic Ibrutinib Therapy Effect on Left Atrial Function
关键词
抽象
日期
最后验证: | 11/30/2018 |
首次提交: | 11/18/2018 |
提交的预估入学人数: | 11/19/2018 |
首次发布: | 11/22/2018 |
上次提交的更新: | 12/16/2018 |
最近更新发布: | 12/18/2018 |
实际学习开始日期: | 11/30/2018 |
预计主要完成日期: | 11/30/2019 |
预计完成日期: | 11/30/2020 |
状况或疾病
相
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - patients with haemato-oncologic diseases (including chronic lymphocytic leukemia, Mantle-cell lymphoma, Waldenstrom macroglobulinaemia, etc.) - patients prescribed with chronic ibrutinib therapy - patients who are able to understand and sign informed consent Exclusion Criteria: - patients with haemato-oncologic diseases who were prescribed with concomitant chemotherapy which can impact left atrial function - patients < 18 years old - patients with known or at initial echocardiography established dilated cardiomyopathy with left ventricular ejection fraction < 35% - patients with permanent atrial fibrillation and dilated left atrium or dilated both atriums - patients implanted with cardiac implantable electronic devices - patients who underwent cardiac surgery - patients with congenital heart diseases (surgically corrected or not) - patients with severe valvular pathology - patients with terminal renal disease - patients with chronic obstructive pulmonary disease - GOLD grade 4 - patients with life expectancy < 12 months - patients not willing to undergo clinical follow-up or sign informed consent - patients recruited in another clinical study |
结果
主要结果指标
1. left atrial function change [initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy]
次要成果指标
1. left ventricular ejection fraction change [initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy]
2. left ventricular diastolic function change [initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy]
3. left atrial volume change [initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy]
4. P wave duration change [initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy]
5. left atrial pump function change [initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy]
6. atrial fibrillation incidence [initial measurement, 3 months, 6 months and 12 months after initiation of ibrutinib therapy]