Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Time to first event of adjudicated CV death mortality or adjudicated HHF
研究概览
简要总结
The study aims to describe the clinical characteristics and clarify the predictors of the short- and long-term outcomes of RHF patients, further assist the diagnosis, risk stratification and treatment of RHF.
详细描述
Right heart failure(RHF) is a clinical syndrome with symptoms, signs, and evidence of right ventricular systolic and/or diastolic dysfunction. For many years, it was largely neglected in the consideration of left-sided heart failure, while it is now evident that RHF is not only common but its presence also strongly contributes to increased morbidity and mortality. The in-hospital mortality of RHF is 7%, and the 30-day readmission rate is 20%. Therefore, diagnosis, potential treatment strategies, and prognosis improvement have become an unmet need in the field of cardiovascular disease.
In clinical practice, accurate diagnosis of RHF is the key to timely initiation of treatment and improvement of prognosis. Although current guidelines recommend clinical symptoms and signs combined with echocardiography, cardiac magnetic resonance, and other imaging means to evaluate right heart dysfunction for comprehensive diagnosis of right heart failure, the key diagnostic indicators included are inconsistent, the weight ratio of each indicator is different, the diagnostic threshold is not uniform, and the lack of comprehensive diagnostic model system brings great challenges to clinical practice.
This study aims to integrate multiple clinical biomarkers, imaging, and hemodynamic data to describe the clinical characteristics, establish noninvasive easy-to-use diagnosis models for right heart failure, and explore the risk factors for short- and long-term poor prognosis in patients with RHF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Aged ≥18 years at the time of consent
- •Acceptation of right heart catheterization examination
- •Able to perform the entire protocol
排除标准
- •Life expectancy of less than 1 year based on the investigator's clinical judgment
- •Pregnant or nursing
- •Planned to undergo heart transplantation or device implantation
- •Acute coronary syndrome, uncontrolled severe arrhythmia and shock.
结局指标
主要结局
Time to first event of adjudicated CV death mortality or adjudicated HHF
时间窗: 24 weeks
The composite primary endpoint for this trial is the time to first event of adjudicated CV death or adjudicated hospitalization for heart failure （HHF） in patients with right heart failure.
次要结局
- Time to all-cause mortality(24 weeks)
- Occurrence of adjudicated HHF (first and recurrent)(24 weeks)
- Time to adjudicated CV death(24 weeks)
- Change in renal function from baseline over time(24 weeks)
- Change in ECG data from baseline over time(24 weeks)
- Time to first all-cause hospitalisation(24 weeks)
- Composite of time to first event of all-cause mortality and all cause hospitalisation(24 weeks)
- Change in NYHA class from baseline at week 24(24 weeks)
- Changes in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) from baseline over time(24 weeks)
- Change in liver functions from baseline over time(24 weeks)
- Change in echocardiographic data from baseline over time(24 weeks)
研究者
Jingyi Ren
Professor
China-Japan Friendship Hospital