Serial Biomarker Measurements and New Echocardiographic Techniques in Chronic Heart Failure Patients Result in Tailored Prediction of Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 2
- 主要终点
- The composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure.
研究概览
简要总结
The Bio-SHiFT study aims to investigate whether disease progression in individual patients with chronic heart failure (CHF) can be accurately assessed by serial measurements of disease-related (novel) biomarkers. Secondary objectives of the study include comparison of 2D- with real-time 3D-echocardiography in CHF patients and comparison of Speckle tracking with tissue Doppler imaging (TDI) in CHF patients, and relating these echocardiographic measurements to clinical outcome.
Bio-SHiFT is a prospective, observational, multi-center, cohort study in men and women, aged 18 years or older, visiting the outpatient clinic. Blood samples are taken at the day of inclusion and at follow-up visits, which are performed every 3 months until the end of the scheduled follow-up. Clinical data are collected at baseline and at each 3-month follow-up visit. Echocardiography including TDI, Speckle tracking and 3D-echocardiography is performed in a subset of patients, at baseline and during follow-up at 6-month intervals. The primary endpoint is the composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure.
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
- •Men and women, aged 18 years or older, capable of understanding and signing informed consent
- •Diagnosis of chronic heart failure (with diminished ejection fraction or with normal ejection fraction), according to the guidelines of the European Society of Cardiology (ESC)
排除标准
- •Heart failure secondary to circulatory high output conditions
- •Scheduled for surgery or intervention for both coronary and non-coronary indication
- •Severe renal failure for which dialysis is needed
- •Known moderate or severe liver disease
- •Chronic Obstructive Pulmonary Disease (COPD) Gold stage IV
- •Congenital heart disease
- •Coexistent condition with life expectancy ≤ 1 year
- •Unlikely to appear at all scheduled follow-up visits
- •Linguistic barrier
结局指标
主要结局
The composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure.
时间窗: maximum follow-up is 2.5 years
次要结局
- Cardiovascular death(maximum follow-up is 2.5 years)
- Left ventricular assist device implantation(maximum follow-up is 2.5 years)
- Cardiac transplantation(maximum follow-up is 2.5 years)
- Re-hospitalization for acute or worsened heart failure(maximum follow-up is 2.5 years)
- Cardiovascular disease: myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG)(maximum follow-up is 2.5 years)
- All-cause mortality(maximum follow-up is 2.5 years)
研究者
Eric Boersma
Prof.dr.
Erasmus Medical Center