Systolic Dysfunction to Congestive Heart Failure Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Composite endpoint of hospitalization for heart failure and cardiovascular death
研究概览
简要总结
TransitionCHF aims to recruit a unique cohort of patients with asymptomatic left ventricular dysfunction (NYHA I) to study the progression to symptomatic (>NYHA I) HF and to identify parameters/ biomarkers promoting and predicting the individual risk of transition. Results from TransitionCHF Cohort Study will inform and refine current treatment guidelines. The implementation of common patient data sets and biobanking standards will enable data and biomaterial sharing with other study groups of the German Center for Cardiovascular Research (DZHK). This study will set the standard for a unique DZHK heart failure database and Biobank for innovative preclinical and clinical trials.
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
- •Asymptomatic systolic dysfunction (defined as: ejection fraction < 40% by echocardiography or MRI; documented within the last 3 months prior to baseline visit)
- •A maximum of one hospitalization for heart failure (defined as hospitalization with signs and symptoms of heart failure requiring intravenous loop diuretic therapy within 48 hours after hospital admission) at least 2 years prior to the baseline visit
- •No heart failure symptoms (NYHA II, III or IV) upon inclusion
- •6MWD ≥ 80% of reference values
- •Written informed consent
- •Age ≥ 18 years
排除标准
- •Symptomatic heart failure (NYHA>I) at baseline visit
- •Any significant valvular disease (> 2nd degree)
- •Severe pulmonary disease (e.g. FEV1/FVC <0.7 and FEV1<50%)
- •Severe renal disease (GFR < 15 ml/min)
- •ejection fraction at baseline visit ≥ 50% by echocardiography or MRI
- •Life expectancy < 1 year
- •Pericardial disease
- •Hypertrophic cardiomyopathy
- •Myocardial infarction within the last 3 months
- •Planned cardiac surgical intervention within 3 months after inclusion
- •Geographical reasons (e. g. patients living outside Germany or planning to move abroad)
- •Inability to give informed consent (e. g. mental disorders)
- •Therapy with loop diuretics (e.g. torasemide, furosemide, piretanide) within 4 weeks prior to inclusion/baseline visit
结局指标
主要结局
Composite endpoint of hospitalization for heart failure and cardiovascular death
时间窗: 0.5 - 13 years
次要结局
未报告次要终点
研究者
Gerd Hasenfus
Prof. Dr. med. Gerd Hasenfuß
University of Göttingen