Tricuspid Regurgitation Hamburg Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Unplanned tricuspid valve intervention
研究概览
简要总结
Tricuspid regurgitation (TR) is frequent and has been directly related to high mortality rates. The pathophysiology of TR is mainly functional as it occurs predominantly in the context of left-sided heart disease, pulmonary hypertension, or atrial fibrillation. Surgery is currently the primary treatment option in patients with functional TR. However, isolated tricuspid valve surgery is associated with an intolerable high risk of operative mortality and poor outcomes. New transcatheter options could be used in high-surgical risk patients. However, with often severely dilated annuli with a non-planar and elliptical shape, absence of calcification, and proximity of structures, the tricuspid valve anatomy poses many challenges.
Predictors of outcome are yet to be defined in patients with TR in order to improve risk prediction for the different treatment modalities (medical, surgical, interventional). The Tricuspid Regurgitation Hamburg Cohort (TRUTH) aims to monitor patients with relevant TR, irrespective of the underlying etiology or therapeutic approach. In addition to available evidence from previously published clinical trials, elaborate prospective clinical registries, such as TRUTH, that monitor clinical routine and current practice, will be of significant importance to further enhance therapeutic options.
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
- •Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation.
- •Individuals over the age of 18 years.
- •Patients with clinically relevant tricuspid regurgitation (≥ severe TR, at least Grade III of V)
排除标准
- •Insufficient knowledge of the German language, to understand study documents and interview without translation
- •Physical or psychological incapability to cooperate in the investigation
结局指标
主要结局
Unplanned tricuspid valve intervention
时间窗: 6-60 months
Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or assist device implantation, e.g. as assessed by patient interviews.
All-cause mortality
时间窗: 6-60 months
Incidence of death from any cause.
Rehospitalization for congestive heart failure
时间窗: 6-60 months
Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews.
Tricuspid regurgitation severity
时间窗: 6-60 months
Tricuspid regurgitation (TR) severity measured by transthoracic and transesophageal echocardiography. Assessment of TR severity according to current recommendations for valvular heart disease.
Cardiovascular mortality
时间窗: 6-60 months
Incidence of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovascular accident.
次要结局
- Change in 6-minute-walking-test (6MWT) distance(6-60 months)
- Change in New York Heart Association (NYHA) functional class(6-60 months)
- Change in quality of life(6-60 months)