Shear Wave Elastography of the Liver and Predictions of Morbidity and Mortality in Subjects Undergoing Advanced Heart Failure Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Liver stiffness (LS) measurements with development of post-LVAD RHF.
研究概览
简要总结
In individuals needing a left ventricular assist device (LVAD), right heart failure (RHF) is a serious complication post-surgery, associated with worsened outcomes including mortality. However, predictors of decompensation after LVAD are not well established. Liver dysfunction pre-LVAD has been shown to be associated with poor outcomes post-LVAD, but the interplay between liver abnormalities and RHF post-LVAD is not well characterized. Liver stiffness (LS) is a measure associated with certain types of liver abnormalities (e.g., liver fibrosis; cirrhosis).
Thus, we hypothesize that elevated LS measured by SWE is associated with increased morbidity and mortality in patients undergoing LVAD implantation and yields increased need for advanced postoperative HF therapies including the use of right ventricular assist devices (RVAD) for the management of RHF.
详细描述
PRESTUDY ASSESSMENTS Note: Assessments that are part of the standard of care and obtained within 3-4 weeks of prestudy assessment visit, are acceptable as part of the screening tests. Results of such tests will be acceptable even if obtained prior to the execution of the Informed Consent.
Prior to entry into the study, the following assessments will be performed to determine if patient is eligible to continue in the study as per section 4.2 and 4.3 describing the inclusion and exclusion criteria for the study.
- A signed Patient Informed Consent Form must be obtained.
- A signed Patient Authorization Form (HIPAA) must be obtained.
- It has been confirmed that the patient meets all inclusion criteria and none of the exclusion criteria.
- Assessment of concomitant medications must be obtained within 4 weeks prior to registration.
ASSESSMENTS DURING STUDY
The following evaluations will be performed during the study:
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
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients ≥18 years of age.
- •Patient must be diagnosed with HF.
- •Patient must be referred for an evaluation for advanced HF therapy (i.e., LVAD or heart transplantation).
- •Patient must be accessible for treatment and follow-up.
- •Outpatients only
- •All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.
排除标准
- •Severe obesity (body mass index [BMI] >35 kg/m2) or severe abdominal obesity
- •History of chronic or acute liver disease.
- •Positive test for hepatitis C antibody or hepatitis B surface antigen reactivity
- •History of intravenous drug or heavy alcohol use
- •Patients with ultrasound data showing liver surface nodularity as a surrogate for advanced fibrosis.
结局指标
主要结局
Liver stiffness (LS) measurements with development of post-LVAD RHF.
时间窗: 24 months
An assessment of liver stiffness will be performed by shear wave elastography using a Supersonic Imagine Aixplorer ShearWave™ ultrasound machine.
次要结局
- 30 day in-hospital mortality rate(30 days)
- 1 year mortality rate(1 year)