Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure: DRAGON-HF Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Number of participants with cardiaovascular death after 5-year follow up
研究概览
简要总结
The objective of this work is to investigate and then to sequence new biomarkers in the blood of patients with heart failure, and study their diagnostic, risk stratification and prognostic value.
详细描述
Blood samples (plasma or serum) for heart failure patients presenting dyspnea or edema and with increased NT-proBNP. The objective of this work is to investigate and then to sequence new proteins or microRNAs in the blood of these patients for diagnostic, risk stratification and prognostic purpose.
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
- 是
入选标准
- •Age > 18 years of age
- •Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
- •Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment
排除标准
- •Life expectancy <1 year due to causes other than HF such as advanced cancer
- •Cardiac transplantation or revascularization indicated or expected within 6 months
- •Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec <1 L (when diagnosed as standard of care)
- •Subject unable or unwilling to provide written informed consent
- •Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
- •Progressive neurological disease
结局指标
主要结局
Number of participants with cardiaovascular death after 5-year follow up
时间窗: 5 years
The cardiovascular mortality after 5-year follow up will be assessed to detect prognostic values of circulating biomarkers
Time to decompensated heart failure (HF) requiring in-patient admission or ER visit or IV diuretic therapy in the outpatient realm
时间窗: 5 years
New onset of classic symptoms and signs of destabilized HF, including lower extremity edema, jugular venous distension, bibasilar crackles, orthopnea and paroxysmal nocturnal dyspnea.
次要结局
- Change From Baseline in left ventricular ejection fraction(5 years)
- Comparison of new biomarker with NT-ProBNP on diagnostic value in patients with heart failure(1 year)
- Change From Baseline in left ventricular end-systolic volume(5 years)
研究者
Ya-Wei Xu
Professor
Shanghai 10th People's Hospital