Investigating Myocardial Remodelling in the Failing Human Heart
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- MRI functional parameters including Left Ventricular Ejection Fraction and Global Longitudinal Strain
研究概览
简要总结
Despite improvements in therapy, heart failure is a disease with high mortality and accelerating prevalence. To improve patient care, it is necessary to better understand the features and underlying mechanisms of myocardial remodeling; how it manifests in vivo and its underlying cellular and extracellular changes. The RELAX study will offer insight into myocardial remodeling, by comprehensively assessing function and structure of failing human hearts, and investigate its underlying cellular and extracellular changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible for heart transplantation
- •Willingness to participate in the present study and ability to understand and sign the written informed consent
排除标准
- •Patients under the age of 18.
结局指标
主要结局
MRI functional parameters including Left Ventricular Ejection Fraction and Global Longitudinal Strain
时间窗: 1 years
Measurement of myocardial function by in-vivo methods. In-vivo myocardial function will be obtained by MRI and echocardiography. Measurements include LVEF and GLS.
MRI morphological parameters including LVEDV and LVESV.
时间窗: 1 years
Measurement of myocardial morphology by in-vivo methods including MRI and ultrasound. The expected outcome in regards to morphology is varying degrees of geometrical abnormalities.
Myocardial stiffness measured by MRI and ex-vivo methods.
时间窗: 1 year
Measurement of myocardial stiffness by in-vivo and ex-vivo methods. In-vivo myocardial stiffness will be measured by MRI. The expected outcome is varying degrees of stiffness in accordance with the underlying pathology as well as regionally in the heart. Ex-vivo methods include stiffness measurements by histology and protein analysis.
次要结局
未报告次要终点
研究者
Ivar Sjaastad
Professor
Oslo University Hospital