Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis: Prognostic Significance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The longitudinal changes in left and right ventricular global strain after chemotherapy in cardiac light chain amyloidosis
研究概览
简要总结
The purpose of this study to assess the longitudinal changes in left and right ventricular global strain after chemotherapeutic strategies in cardiac light chain amyloidosis.
详细描述
Light chain amyloidosis is a disease characterized by localized or systemic accumulation of amyloid fibrils in tissues caused by abnormal folding of light chain immunoglobulins and affecting organ functions. In the treatment, chemotherapeutic agents are used that prevent the clonal proliferation of plasma cells in the bone marrow. Although the hematological response is standardized in evaluating the treatment response, there is no adequately effective method for assessing cardiac response. Despite the use of various scores, imaging-based systems continue to be developed to increase the sensitivity of these methods.
After being informed about the study, it is planned to recruit and follow-up AL-Amyloidosis patients with cardiac involvement who are currently receiving/planned chemotherapy followed by hematology or who are planned for bone marrow transplantation within 1 year after obtaining written consent from the patients.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Patients who give the informed consent
- •Patients with cardiac primary light chain amyloidosis or due to multiple myeloma who are newly diagnosed, currently receiving chemotherapeutic treatment, or are scheduled for bone marrow transplantation
排除标准
- •A history of myocardial infarction, coronary artery disease, PCI and revascularization
- •< 18 years old
- •A history of severe aortic and mitral valve disease
- •Patients who do not give the informed consent
- •A history of severe hypertension (SBP>180 mmHg or DBP ≥110 mmHg or the need to use three or more antihypertensive agents)
- •Stable coronary artery patients with ischemia data in stress tests (exertion test, myocardial perfusion scintigraphy)
- •Presence of non-amyloidosis, systemic, inflammatory or autoimmune disease
- •Patients whose cardiac imaging is not interpretable
结局指标
主要结局
The longitudinal changes in left and right ventricular global strain after chemotherapy in cardiac light chain amyloidosis
时间窗: Change from Baseline left and right ventricular global strain at 1 year
In this study, the effects of treatment strategies on left and right ventricular global and regional strain and its relationship with mortality and morbidity will be investigated in patients with AL-amyloidosis, who are still under treatment, and newly diagnosed with AL-amyloidosis.
次要结局
- Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging(Baseline, and 1st, 3rd, 6th, 12th Month follow-up)
研究者
Deniz Mutlu
Principal Investigator
Istanbul University - Cerrahpasa (IUC)